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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 1-47: AS 4259-1995, ancillary devices for expired air resuscitation. (Anesthesias)

Date of Standard: 1995. 
Address of Standards Development Organization:
 Standards Australia (AS)
  1 The Cresent
  Homebush, 0
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
CPR facemasks and shields and non-breathing valves
Processes Affected:
510(K), Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Clause 10.1 Table 3 is not recognized
Clause 10.4 is not recognized
Clause 10.8 is not recognized
Clause 10.16 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5870 Valve, Non-Rebreathing Class 2 CBP
Relevant Guidance:
Draft Reviewer Guidance of Face Masks and Shields for CPR, March 16, 1994
FDA Technical Contact:
 Chan Lee
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2543
  Silver Spring MD 20993
  301/796-6267
  email: chan.lee@fda.hhs.gov
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