Mappings for the StructureDefinition-us-core-device Profile.
US Core Implanted Device Profile |
Device | |
identifier | The serial number which is a component of 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. |
udi | |
deviceIdentifier | The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. |
name | Propietary/Trade Name of the medical Device as used in the labeling or catalog |
carrierHRF | A unique device identifier (UDI) on a device label in plain text |
carrierAIDC | A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology. |
issuer | All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other |
type | Type description using GMDN or other code system |
lotNumber | 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. |
manufacturer | N/A |
manufactureDate | The date a specific device was manufactured - which is a component of 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 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”. |