| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
036
|
Date of Entry 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
|
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. |
|
Transition Period
| FDA recognition of CGA C-9:2013 [Rec# 1-101] will be superseded by recognition of CGA C-9:2019 [Rec# 1-170]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-101] until June 7, 2026. After this transition period, declarations of conformity to [Rec# 1-101] will not be accepted. |
|
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*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
