UDI-DI (A device Identifier) and UDI-PI (A production identifier)
UDI-DI is a singular numeric or alphanumeric code that is specific to a device model and also used as an ‘Access Key’ to information stored in the UDI database.
Note: UDI-DI is currently the GTIN (Global Trade Item Number) number from organizations such as GS1.
UDI-PI is a numeric or alphanumeric code that reflects how the device is controlled and provides information.
Different Manufacturing Identifiers may include any combination of serial numbers, batch/batch numbers, manufacturing or expiration dates.
UDI-DI and UDI-PI Formats
You can define some numbers in parentheses in the UDI fragment. Each of these numbers provides specific information about the product:
(01) UDI-DI Code
(10) Lot Number
(11) Date of Manufacture
(17) Expiry Date
(21) Serial Number
Basic UDI-DI
The Basic UDI-DI is used in the database and in the relevant documentation to connect with devices with the same intended use, risk class and basic design and manufacturing characteristics (E.g.: certificates, declaration of conformity, technical documentation and safety and clinical performance summary) are the main switches. It is independent of the packaging/label of the appliance and is not visible on any commercial item.
See. https://www.gs1.org/services/gmn-generator
The Implementing Regulation European Commission (EU) 2019/939, published on 6 June 2019, lists the institutions below where we can obtain the UDI codes.
- GS1
- HIBCC (Health Industry Business Communications Council)
- ICCBBA
- IFA GmbH (Informationsstelle für Arzneispezialitäten)