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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, pressure and accessories
Regulation Description Pressure tubing and accessories.
Product CodeBYX
Regulation Number 868.5860
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component falling 6
Crack 5
Detachment of device component 5
Leak 3
Detachment of device or device component 3
Use of Device Issue 3
Electrical issue 2
Other (for use when an appropriate device code cannot be identified) 2
Device maintenance issue 2
Foreign material present in device 1
Air leak 1
Material perforation 1
No Information 1
Break 1
Flaked 1
Valve(s), sticking 1
Failure to deliver 1
Corrosion 1
Tube(s), buckling of 1
Total Device Problems 41

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