Publication

M-20: Guideline for the Implementation of Unique Device Identification

Abstract

This publication applies to manufacturers, distributors, and specification developers of medical devices used in the medical gas and gas equipment industry.

This publication does not apply to the manufacturing, reprocessing, and requalifying of cylinders or plain cylinder valves or the combining of the two because they are not classified as medical devices.

This publication is based upon:
• 21 CFR Part 830 [1];
• FDA’s GUDID guidance [2]; and
• CGA PS-53, Position Statement on Pressure Regulators, Cylinder Valves, and Cylinders with Valves as Medical Devices [3].

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Properties

Edition:
2
Published:
December 2020
Status:
Available To the Public
Size:
5 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Equipment

Cataloging

Category
Medical Gases     Standards & Guidelines
Keywords
medical device
Related
PS-53