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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adminstration set docking station
Regulation Description Intravascular administration set.
Definition Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
Product CodeODI
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1

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