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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device conserver, oxygen
Product CodeNFB
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNASTHETICS LLC
  SUBSTANTIALLY EQUIVALENT 1
EFFORTLESS OXYGEN. LLC
  SUBSTANTIALLY EQUIVALENT 1
INCOBA LTD. D/B/A DYNARIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Flare or Flash 2 2
Improper Flow or Infusion 1 1
Material Deformation 1 1
No Flow 1 1
Scratched Material 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Sharp Edges 1 1
Thermal Decomposition of Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Burn(s) 1 1
Ulcer 1 1
Pressure Sores 1 1
Superficial (First Degree) Burn 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Inovo, Inc II Jul-29-2019
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