What A Unique Device Identifier Will Look Like

Image from FDA website

As part of the FDA’s UDI final rule, the government agency put together a fictitious example of what a Unique Device Identifier on a medical device would look like.  The label contains information about the product name, its expiration date, lot numbers, manufacturer information, barcode and details about the item.

(The information below is from the FDA’s Medical Devices webpage)

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

1. the lot or batch number within which a device was manufactured;
2. the serial number of a specific device;
3. the expiration date of a specific device;
4. the date a specific device was manufactured;
5. 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.

As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information.