Intravascular Administration Set, Automated Air Removal System
OKL · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5445
Classification
FDA Product Code
OKL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5445
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.