Assigning UDIs to Medical Devices
A UDI – which is a unique numeric or alphanumeric code – consists of two parts, the Device Identifier (DI) and the Production Identifier (PI).
The Device Identifier (DI) is a mandatory, fixed portion that identifies the labeler and the specific version or model of a device. An example of this type of identifier is a GTIN.
The Production Identifier (PI) is a conditional, variable portion of the UDI that identifies one or more of the following when included on a device label:
- Lot or batch number
- Serial number
- Expiration date (YYYY-MM-DD format required)
- Manufacture date (YYYY-MM-DD format required)
- Distinct identification code required by 21CFR1271.290 for any human cell, tissue, or cellular- and tissue-based product (HCT/P) regulated as a device.
Class I Devices only require the Device Identifier (DI).
Class II and III Devices require both the Device Identifier (DI) and Production Identifier (PI).
The UDI must be presented in two forms:
- Easily-readable plain text
- Automatic Identification and Data Capture (AIDC) technology