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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valve, pressure relief, cardiopulmonary bypass
Product CodeMNJ
Regulation Number 870.4400
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Dec-27-2013
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