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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device conserver, oxygen
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeNFB
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 11
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 2
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
FLOTEC
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 4
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Flare or flash 1
Gas leak 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sunrise Medical II Apr-21-2007
2 Superior Products Inc II Jan-23-2008

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