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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device piston syringe with neuraxial connector - epidural and peripheral delivery
Regulation Description Piston syringe.
Definition A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code includes epidural and peripheral administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Product CodeQEH
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1


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