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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 1-101
Standard
CGA C-9:2013
Standard Color Marking of Compressed Gas Containers for Medical Use
Scope/Abstract
This standard provides guidance to prevent errors in selecting medical gases for human administration. Guidance includes labeling, CGA connections, and colors for different gases.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 James J. Lee
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  301-796-8463
  James.J.Lee@fda.hhs.gov
Standards Development Organization
CGA Compressed Gas Associated, Incorporated https://www.cganet.com/
FDA Specialty Task Group (STG)
Anesthesiology
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