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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device supplies, blood-bank
Product CodeKSS
Regulation Number 864.9050
Device Class 1


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
MACOPRODUCTIONS S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
TIMESTRIP UK LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Problem 4 4
Device Difficult to Setup or Prepare 3 3
Material Separation 1 1
Shipping Damage or Problem 1 1
Separation Failure 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Fracture 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6 6
No Information 3 3
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1

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