This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2
Device | Device |
identifier | .id |
udiCarrier | .id and .code |
deviceIdentifier | Role.id.extension |
issuer | Role.id.root |
jurisdiction | Role.scoper |
carrierAIDC | Role.id.extension |
carrierHRF | Role.id.extension |
entryType | NA |
status | .statusCode |
distinctIdentifier | .lotNumberText |
manufacturer | .playedRole[typeCode=MANU].scoper.name |
manufactureDate | .existenceTime.low |
expirationDate | .expirationTime |
lotNumber | .lotNumberText |
serialNumber | .playedRole[typeCode=MANU].id |
type | .playedRole[typeCode=MANU].code |
modelNumber | .softwareName (included as part) |
partNumber | .playedRole[typeCode=MANU].id |
patient | .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] |
owner | .playedRole[typeCode=OWN].scoper |
contact | .scopedRole[typeCode=CON].player |
location | .playedRole[typeCode=LOCE].scoper |
url | .telecom |
note | .text |
safety | NA |
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 | |
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. |
displayName | |
definition | |
udiCarrier | |
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. |
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 |
jurisdiction | |
carrierAIDC | A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology. |
carrierHRF | A unique device identifier (UDI) on a device label in plain text |
entryType | |
status | |
statusReason | |
distinctIdentifier | 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”. |
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. |
serialNumber | |
deviceName | |
name | |
type | |
modelNumber | |
partNumber | |
type | |
specialization | |
systemType | |
version | |
version | |
type | |
component | |
value | |
property | |
type | |
valueQuantity | |
valueCode | |
patient | |
operationalStatus | |
value | |
reason | |
associationStatus | |
value | |
reason | |
owner | |
contact | |
location | |
url | |
note | |
safety | |
parent | |