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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Product CodeFIP
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERIWATER
  SUBSTANTIALLY EQUIVALENT 9
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 6
MAR COR
  SUBSTANTIALLY EQUIVALENT 2
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MINNTECH
  SUBSTANTIALLY EQUIVALENT 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
OSMONICS
  SUBSTANTIALLY EQUIVALENT 1
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to flush 2
Device Cleaning Issue 2
Disinfection or Sterilization Issue at User Location 2
No Known Device Problem 1
Electrical issue 1
Maintenance does not comply to manufacturers recommendations 1
Overheating of device or device component 1
Bacterial contamination of device 1
Device maintenance issue 1
Total Device Problems 12

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 1 0 3 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AmeriWater Inc II Sep-06-2012
2 Mar Cor Purification II May-06-2014
3 Mar Cor Purification II Mar-14-2014
4 Mar Cor Purification II Mar-13-2014

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