The medical device (internally or externally).

Frequently used coding systems to identify devices are Health Industry Bar Code (HIBC) or GS1's Global Trade Item Number (GTIN). If one of these systems is used, the device identification happens on the basis of a UDI. Next to these two, other systems to identify devices are allowed by the zib, as long as such a system allows for unique identification of the device.

In all cases the full identifier will be populated in .identifier. If the identifier is a UDI in particular, it should also be populated in udiCarrier.carrierHRF, and the element udiCarrier.issuer is used to indicate which 'coding system' is used. Moreover the identifier may be broken down into several parts in that case, namely .udiCarrier.deviceIdentifier, .manufactureDate, .expirationDate, .lotNumber and .serialNumber. For GTIN, guidance is given at the respective elements in this profile and is based on https://www.gs1.org/industries/healthcare/udi. For HIBC please consult the the Supplier Labeling Standard that can be found at https://www.hibcc.org/udi-labeling-standards/barcode-standards/, as conversion into the several parts is less straightforward.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Unique identification of the product, such as the serial number. The identifier may only be used if it also identifies the resource.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Unique identification of the product, such as the serial number. The identifier may only be used if it also identifies the resource.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Unique device identifier (UDI) assigned to device label or package. Note that a udiCarrier is only applicable if the zib concept ProductID actually contains a UDI, e.g. an ID according to GTIN or HIBC.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Status of the Device availability.

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

The availability status of the device.

The code of the type of product.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Descriptive information, usage information or implantation information that is not captured in an existing element.

For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

Textual description of the product.

Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

The medical device (internally or externally).

Frequently used coding systems to identify devices are Health Industry Bar Code (HIBC) or GS1's Global Trade Item Number (GTIN). If one of these systems is used, the device identification happens on the basis of a UDI. Next to these two, other systems to identify devices are allowed by the zib, as long as such a system allows for unique identification of the device.

In all cases the full identifier will be populated in .identifier. If the identifier is a UDI in particular, it should also be populated in udiCarrier.carrierHRF, and the element udiCarrier.issuer is used to indicate which 'coding system' is used. Moreover the identifier may be broken down into several parts in that case, namely .udiCarrier.deviceIdentifier, .manufactureDate, .expirationDate, .lotNumber and .serialNumber. For GTIN, guidance is given at the respective elements in this profile and is based on https://www.gs1.org/industries/healthcare/udi. For HIBC please consult the the Supplier Labeling Standard that can be found at https://www.hibcc.org/udi-labeling-standards/barcode-standards/, as conversion into the several parts is less straightforward.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

A human language.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Unique identification of the product, such as the serial number. The identifier may only be used if it also identifies the resource.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Unique identification of the product, such as the serial number. The identifier may only be used if it also identifies the resource.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

The reference to the definition for the device.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Unique device identifier (UDI) assigned to device label or package. Note that a udiCarrier is only applicable if the zib concept ProductID actually contains a UDI, e.g. an ID according to GTIN or HIBC.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Note that FHIR strings SHALL NOT exceed 1MB in size

Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :

1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

A coded entry to indicate how the data was entered.

Note that FHIR strings SHALL NOT exceed 1MB in size

Codes to identify how UDI data was entered.

Supports a way to distinguish hand entered from machine read data.

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. In the GS1 standard this element represents the GTIN itself - e.g. 01234567891234 - as part of the Application Identifier (AI), namely AI(01).

Note that FHIR strings SHALL NOT exceed 1MB in size

Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

A coded entry to indicate how the data was entered.

Note that FHIR strings SHALL NOT exceed 1MB in size

Codes to identify how UDI data was entered.

Supports a way to distinguish hand entered from machine read data.

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Note that FHIR strings SHALL NOT exceed 1MB in size

Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

A coded entry to indicate how the data was entered.

Note that FHIR strings SHALL NOT exceed 1MB in size

Codes to identify how UDI data was entered.

Supports a way to distinguish hand entered from machine read data.

Status of the Device availability.

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

The availability status of the device.

Reason for the dtatus of the Device availability.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The availability status reason of the device.

The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

A name of the manufacturer.

Note that FHIR strings SHALL NOT exceed 1MB in size

The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11).

The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17).

The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10).

Note that FHIR strings SHALL NOT exceed 1MB in size

The serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21).

Alphanumeric Maximum 20.

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The name of the device.

Note that FHIR strings SHALL NOT exceed 1MB in size

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Note that FHIR strings SHALL NOT exceed 1MB in size

The type of name the device is referred by.

The model number for the device.

Note that FHIR strings SHALL NOT exceed 1MB in size

The part number of the device.

Alphanumeric Maximum 20.

The code of the type of product.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The standard that is used to operate and communicate.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The version of the standard that is used to operate and communicate.

Note that FHIR strings SHALL NOT exceed 1MB in size

The actual design of the device or software version running on the device.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of the device version.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

A single component of the device version.

The version text.

Note that FHIR strings SHALL NOT exceed 1MB in size

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Property value as a quantity.

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

Property value as a code, e.g., NTP4 (synced to NTP).

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Patient information, If the device is affixed to a person.

According to https://www.hl7.org/fhir/r4/compartmentdefinition-patient.html, this reference may not be populated. Therefore, no reference to the nl-core-Patient profile is defined here.

If the device is implanted in a patient, then need to associate the device to the patient.

An organization that is responsible for the provision and ongoing maintenance of the device.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Contact details for an organization or a particular human that is responsible for the device.

used for troubleshooting etc.

The place where the device can be found.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Device.location can be used to track device location.

A network address on which the device may be contacted directly.

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Descriptive information, usage information or implantation information that is not captured in an existing element.

For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

The individual responsible for making the annotation.

Organization is used when there's no need for specific attribution as to who made the comment.

Indicates when this particular annotation was made.

Textual description of the product.

Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

Provides additional safety characteristics about a medical device. For example devices containing latex.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The parent device.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.