
UDI Basics | FDA - U.S. Food and Drug Administration
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...
Unique Device Identification (UDI) - Healthcare - GS1
According to the International Medical Device Regulators Forum (IMDRF), a Unique Device Identification (UDI) system is intended to provide a single, globally harmonised system for positive identification of medical devices through distribution and use.
UDI-PI and the MDR - Is the UDI-PI required for all devices ...
2019年6月21日 · UDI-PI - The UDI-PI is used to identify specific production series of a medical device (batch, serial number etc.). In case of minor non-relevant changes the UDI-PI will can also be used for identification of specific generations of the device.
GS1 UK | In UDI, what are Production Identifiers (PI)?
2024年11月13日 · Discover what Production Identifiers (PI) are in the UDI (Unique Device Identifier) system. Learn how they ensure traceability, support medical device compliance, and improve product safety and tracking.
2017年3月24日 · Unique Device Identification (UDI) improves patient safety and healthcare business processes and will require significant implementation investments by manufacturers, providers and other healthcare organisations.
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information
Unique Device Identification System (UDI System) | FDA
When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize...
Unique Device Identifier - UDI - European Commission - Public …
2024年7月30日 · The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components. a device identifier (UDI-DI) a production identifier (UDI-PI)
Unique Device Identification - Wikipedia
Devices and packaging are to be marked with a device identifier ("UDI-DI"), identifying manufacturer and product, and a production identifier ("UDI-PI)", consisting of, e.g., the LOT and/or expiration date. Custom-made and investigational devices are …
GS1 Unique Device Identification (UDI) - BarcodeFAQ
The GS1 UDI barcode combines the Device Identifier (DI), also known as the GTIN by GS1.org, and the Production Identifier (PI).