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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, processing for frozen blood
Product CodeKSW
Regulation Number 864.9145
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 2 2
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anemia 2 2
Hearing Impairment 1 1
Tinnitus 1 1

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