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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, water purification, general medical use
Definition The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.
Product CodeNHV
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
AQUA-TOOLS
  SUBSTANTIALLY EQUIVALENT 1
ECOLAB INC.
  SUBSTANTIALLY EQUIVALENT 1
I3 MEMBRANE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Filtration Problem 4 4
Break 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Bacterial Infection 1 1

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