UDI encoding components

UDI stands for Unique Device Identification, a series of numbers, letters, or characters created using globally recognized device identification and coding standards. It includes both product and manufacturing identifiers, used to uniquely identify medical devices.

The Unique Device Identification consists of a product identifier (DI) and a manufacturing identifier (PI), i.e., UDI = Product Identifier (DI) + Manufacturing Identifier (PI).
The Product Identifier (DI), internationally known as Device Identifier, is a unique code identifying the registrant/filing party, the medical device model/specification, and packaging. It consists of numbers and includes a packaging code, manufacturer identification code, product item code, and check digit. It is a unique code for a specific model and packaging of medical device and can serve as an "access key" for storing information in the Unique Device Identification database. The Manufacturing Identifier (
PI), internationally known as Production Identifier, is a code used to identify data related to the medical device manufacturing process.
The Production Identification Number (UDI-PI) can be customized according to actual application needs, including information such as medical device serial number, production batch number, production date, and expiration date.