What Data Needs to be Included on Unique Device Identifier (UDI)?

A UDI is a unique numeric or alphanumeric code that consists of two parts:

• Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
• 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:
• lot or batch number within which a device was manufactured;
• serial number of a specific device;
• expiration date of a specific device;
• date a specific device was manufactured;
• 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

From fda.gov

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.