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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bag, reservoir
Regulation Description Reservoir bag.
Product CodeBTC
Regulation Number 868.5320
Device Class 1


Premarket Reviews
ManufacturerDecision
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 38
Device Issue 2
Total Device Problems 40

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 2 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 Medline Industries Inc II Jun-25-2008
2 Ventlab Corporation II Sep-20-2008

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