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U.S. Department of Health and Human Services

Product Classification

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Device water, 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
Technical Method Physically occupies space within 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 CodeNZX
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
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
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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