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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enteral specific transition connectors
Regulation Description Gastrointestinal tube and accessories.
Definition Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Product CodePIO
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 294
Failure to sense 9
Failure to infuse 9
Connection issue 2
Free or unrestricted flow 1
Improper flow or infusion 1
Infusion or flow issue 1
Material integrity issue 1
Blockage within device or device component 1
Disconnection 1
Material disintegration 1
Total Device Problems 321

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