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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
BRIDGE TO LIFE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT GEORGES LOPEZ
  SUBSTANTIALLY EQUIVALENT 2
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Dr Franz Koehler Chemie Gmbh II Sep-26-2024
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