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U.S. Department of Health and Human Services

Product Classification

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Device cap, device disinfectant
Regulation Description Intravascular administration set.
Definition Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Physical State A molded cap with a disinfectant pad to fit on a luer access device
Technical Method Fits on a Luer Access Valve to disinfect the valve, then act as physical barrier to contamination
Target Area Intravascular
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQBP
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5440
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
Third Party Review Not Third Party Eligible