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U.S. Department of Health and Human Services

Product Classification

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Device heparin, vascular access flush
Regulation Description Intravascular catheter.
Definition Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Physical State Liquid solution
Technical Method Physically occupies spacewithin the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting.
Target Area Vascular catheter
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeNZW
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