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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dialyzer
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Product CodeJQQ
Regulation Number 862.2050
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiopulmonary Arrest 1 1
No Consequences Or Impact To Patient 1 1
Anaphylactoid 1 1

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