Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Distinct identification code required by §1271.290 (c) for 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.

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.

Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency's UDI system, on device labels, device packages, and in some instances, directly on the device.

The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20. A UDI is composed of: (1) A device identifier —a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and.

2022年10月14日 · Basic UDI-DI (or BUDI-DI for short) is an entirely new method of device identification, one which groups together devices with multiple UDI-DIs. With Basic UDI-DI, the BUDI-DI number links devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.

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.

2024年6月28日 · Comprehensive list of links to the UDI rule and guidances, training for industry, UDI and GUDID technical resources, and dockets.

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 …