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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dialyzer reprocessing system
Product CodeLIF
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
HACH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH
  SUBSTANTIALLY EQUIVALENT 3
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Device expiration issue 3
Use of Device Issue 3
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 7

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 1 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 Hach Co II Sep-04-2009

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