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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mask, oxygen, non-rebreathing
Regulation Description Nonrebreathing mask.
Product CodeKGB
Regulation Number 868.5570
Device Class 1


Premarket Reviews
ManufacturerDecision
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 26
Disconnection 22
Connection issue 15
Inflation issue 7
Loose or intermittent connection 7
Defective item 6
Failure to Adhere or Bond 5
Device damaged prior to use 4
Hole in material 4
Leak 2
Burst 2
No Known Device Problem 1
Not Applicable 1
Fitting problem 1
Material rigid or stiff 1
Crack 1
Total Device Problems 105

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 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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