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 |
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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 |
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udiCarrier |
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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. |
deviceIdentifierSystem |
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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 |
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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 |
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status |
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availabilityStatus |
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biologicalSourceEvent |
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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 |
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name |
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value |
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type |
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display |
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modelNumber |
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partNumber |
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category |
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type |
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deviceVersion |
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type |
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component |
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installDate |
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value |
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conformsTo |
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category |
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specification |
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version |
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property |
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type |
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value[x] |
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mode |
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cycle |
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duration |
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owner |
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contact |
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location |
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url |
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endpoint |
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gateway |
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note |
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safety |
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parent |
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