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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, electric for gravity flow infusion systems
Regulation Description Electronic monitor for gravity flow infusion systems.
Product CodeFLN
Regulation Number 880.2420
Device Class 2

MDR Year MDR Reports MDR Events
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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