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...

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.

Jun 21, 2019 · 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.

Jul 30, 2024 · 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)

A UDI production identifier (UDI-PI) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

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

Nov 24, 2014 · On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you have selected, and make sure they are both machine‑readable and human‑readable.

Nov 13, 2024 · 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.

Sep 27, 2024 · The UDI-PI is the production identifier. It is the dynamic part of the UDI. It tells you about lot number, serial number, manufacturing date, expiration date… But before that, you need the Basic UDI-DI which identifies a group of product. It´s different from the UDI-DI. And also the UDI carrier. Ok, I stop. Are you confused now?

Feb 11, 2025 · UDI-PI: The production identifier identifies each individual instance of a product or batch. Each defibrillator therefore has its own UDI-PI. Read more below about the difference between Basic UDI-DI and UDI-DI. The UDI for medical devices is also required in other countries, for example, by the FDA (see below).