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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Transparent container, volume markings on the syringe barrel, tip cap, plunger stopper and Heparin Lock Flush solution
Technical Method Attaach syringe to access device and flush.
Target Area Heparin lock device or central venous catheter.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePEF
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible