Mappings for the device resource.
UDI is a unique numeric or alphanumeric code that consists of two parts:
(1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and (2)
a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
(2a) the lot or batch number within which a device was manufactured; (2b) the serial number of a specific device; (2c) the expiration date of a specific device; (2d) the date a specific device was manufactured; (2e) 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.
| Device | N/A |
| identifier | The serial number which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. |
| udiCarrier | The full UDI carrier - The Human Readable Form (HRF) representation of the barcode string as printed on the packaging of the device. The 'type' component should be set to “UDI” and the 'system' component to the the appropriate repository url. the additional URL is needed to identify the authoritative source for UDI generation within the jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. This allows a recipient of a UDI to know which database will contain the UDI-associated metadata. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC identifiers cannot be conveyed in FHIR. |
| status | N/A |
| type | The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a devicet. The system uri should be included. Possible URIs include
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1-di
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc-di
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di |
| lotNumber | The lot or batch number within which a device was manufactured - which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. |
| manufacturer | N/A |
| manufactureDate | The date a specific device was manufactured - which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. |
| expirationDate | the expiration date of a specific device - which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. |
| model | N/A |
| version | N/A |
| patient | N/A |
| owner | N/A |
| contact | N/A |
| location | N/A |
| url | N/A |
| note | N/A |
Administration
. Page versions: R5 R4B R4 R3 R2
|
Propose a change