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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, perfusion, kidney, disposable
Regulation Description Isolated kidney perfusion and transport system and accessories.
Product CodeKDL
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
DR. FRANZ KOHLER CHEMIE GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak / Splash 2
Device Issue 1
Total Device Problems 3

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Nov-08-2016
2 Organ Recovery Systems, Inc. II Jan-27-2017

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