The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional, variable portion of the production identifier (PI) of a Unique device Identifier (UDI) . If the content is from an ICCBBA -encoded UDI, the URI to use for the system is: http://hl7.org/fhir/NamingSystem/iccbba-din. GS1 and HIBCC formatted UDIs do not currently convey the DIN element.

*Note to balloters: The Orders and Observations Workgroup has not yet determined whether the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.) and so the need for Donation Identification number is currently being met through this extension. If it is determined a separate resource is to be used for Devices of Human (or other) Origin (tissue, blood, etc.) then this extension may be deprecated in the future. Feedback on this issue is welcome.

Codes to represent the functional status of a device implanted in a patient. Both overall device status and an implant status need to be considered. The implant status should only be used when the device status is active.