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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, nasal, oxygen
Regulation Description Nasal oxygen catheter.
Product CodeBZB
Regulation Number 868.5350
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Defective item 8
Inflation issue 5
Spark 2
Flare or flash 2
Electrical issue 2
No Known Device Problem 1
Packaging issue 1
Device packaging compromised 1
Kinked 1
Occlusion within device 1
Total Device Problems 24

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