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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device disinfectant, subsystem, water purification
Definition Disinfectant intended for reprocessing water purification systems for hemodialysis.
Product CodeNIH
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDIVATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2022 2 2
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Device Handling Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Chemical Exposure 2 2
Burning Sensation 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Discoloration 1 1
Burn(s) 1 1

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