OKL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intravascular Administration Set, Automated Air Removal System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5445
- Medical specialty
- General Hospital
- FDA 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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| Record | Firm | Date | Builder |
|---|---|---|---|
| ClearLine IV (K171954) | Clearline MD | 2018-01-25 | + Add |
| AIRPURGE (DEN080009) | Anesthesia Safety Products, LLC | 2014-03-04 |
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