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:

1. Easily-readable plain text
2. Automatic Identification and Data Capture (AIDC) technology

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