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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemodialyzer, re-use, high flux
Product CodeMSF
Regulation Number 876.5860
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dyspnea 1 1
Itching Sensation 1 1
Rash 1 1
Swelling 1 1
Reaction 1 1
Blood Loss 1 1

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