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U.S. Department of Health and Human Services

Product Classification
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Device saline vascular access flush with integrated alcohol disinfectant device
Regulation Description Intravascular catheter.
Definition Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
Physical State Tip cap of single use pre-filled saline syringe modified to integrate the alcohol disinfection unit (DU).
Technical Method A disinfectant unit is used to disinfect the port prior to flushing the indwelling vascular access device with saline.
Target Area Indwelling vascular access device
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQTI
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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