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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device administrations sets with neuraxial connectors
Regulation Description Intravascular administration set.
Definition The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Product CodePWH
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITHS
  SUBSTANTIALLY EQUIVALENT 1

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