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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 1-81: CGA V-5:2008 (Reaffirmed 2013), diameter-index safety system (noninterchangeable low pressure connections for medical gas applications). (Anesthesias)

Date of Standard: 2008. 
Address of Standards Development Organization:
 Compressed Gas Associated, Incorporated (CGA)
  1725 Jefferson Davis Highway
  Suite 1004
  Arlington, VA 22202-4102
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
Devices Affected:
Devices connected to low pressure medical gases or have low pressure outlets.
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
Relevant Guidance:
Draft Emergency Resuscitator Guidance, April 1993

Draft Reviewer Guidance for Ventilators, July 1995
FDA Technical Contact:
 Sugato De
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2552
  Silver Spring MD 20993
  301/796-6270
  email: sugato.de@fda.hhs.gov
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