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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, gas, oxygen, gaseous-phase
Product CodeCCL
Regulation Number 868.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREOX, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Off-Label Use 1 1
Insufficient Information 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Failure to Deliver 1 1
Improper Flow or Infusion 1 1
Inaccurate Flow Rate 1 1
Insufficient Flow or Under Infusion 1 1
Partial Blockage 1 1
Incorrect Measurement 1 1
Device Sensing Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Known Impact Or Consequence To Patient 1 1
Discomfort 1 1

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