FDA product code OKL

Intravascular Administration Set, Automated Air Removal System

General Hospital·Class 2·21 CFR 880.5445
US regulatory classifications
US Product Code (FDA)
OKL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5445
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Intravascular Administration Set, Automated Air Removal System is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.