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U.S. Department of Health and Human Services

Product Classification

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Device administration set docking station
Regulation Description Intravascular administration set.
Definition Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
Physical State Housing is made of polyethylene, piston is made of silicone
Technical Method Temporary barrier against airborne contaminants
Target Area indirect contact, intravascular administration of fluids
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeODI
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
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
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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