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U.S. Department of Health and Human Services

Product Classification

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Device intravascular administration set, automated air removal system
Definition An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the iv fluid.
Physical State N/A
Technical Method The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air and safety control mechanisms to address hazardous situations. Once air is identified, the device air removal mechanism automatically removes the air from the intravascular administration set with minimal to no interruption in the flow of the IV fluid.
Target Area The device is intended for intravenous infusion systems.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOKL
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5445
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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