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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, LLC
  SUBSTANTIALLY EQUIVALENT 1
B.BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EVOQUA WATER TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS MEDICAL CARE RENTAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY WATER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II Jun-13-2024
2 Fresenius Medical Care Holdings, Inc. II Sep-19-2022
3 Fresenius Medical Care Holdings, Inc. II Jul-25-2022
4 Fresenius Medical Care Holdings, Inc. II Jul-11-2022
5 Fresenius Medical Care Holdings, Inc. II May-07-2021
6 Outset Medical, Inc. II Apr-07-2023
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