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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heparin flush in 0.45% sodium chloride
Regulation Description Intravascular catheter.
Definition The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling. It provides an alternative to clinicians to prevent sodium overload in neonatal patients.
Product CodePEF
Regulation Number 880.5200
Device Class 2

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