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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, nasal, oxygen
Regulation Description Nasal oxygen cannula.
Product CodeCAT
Regulation Number 868.5340
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 3
Crack 1
Fire 1
Hole in material 1
Use of Device Issue 1
Fitting problem 1
Material torqued 1
No code available 1
Total Device Problems 10

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