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CGA M-20

Guideline for the Implementation of Unique Device Identification

standard by Compressed Gas Association , 12/16/2020

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About This Item

 

Full Description

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;
  • FDA’s GUDID guidance; and
  • CGA PS-53, Position Statement on Pressure Regulators, Cylinder Valves, and Cylinders with Valves as Medical Devices.
 

Product Details

Edition:
2nd
Published:
12/16/2020
Number of Pages:
12
File Size:
1 file , 220 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

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    Guideline for the Implementation of Unique Device Identification

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    Guideline for the Implementation of Unique Device Identification

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