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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device valve, non-rebreathing
Regulation Description Nonrebreathing valve.
Product CodeCBP
Regulation Number 868.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
EMERGENCY FILTRATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIRSTAR HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOREMOUNT ENT. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
KIRK SPECIALTY
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
O-TWO SYSTEMS INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Instruction for use issue 1
Improper or incorrect procedure or method 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 0 0 0 0 0 0 0 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Dynarex Corporation II Jul-25-2014
2 Lifeline First Aid LLC II Jul-06-2016

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