| 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. |
| 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 | |
| owner | |
| contact | |
| location | |
| url | |
| note | |
| safety | |
| parent | |
Administration
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