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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, line isolation
Product CodeDRI
Regulation Number 870.2620
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Air Leak 1 1
Crack 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Air Embolism 1 1
No Known Impact Or Consequence To Patient 1 1

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