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.
| Device Type ID | 2717 |
| Device Name | Intravascular Administration Set, Automated Air Removal System |
| 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 Mechani |
| Target Area | The Device Is Intended For Intravenous Infusion Systems. |
| Regulation Description | Intravascular Administration Set, Automated Air Removal System. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| 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) |
| CFR Regulation Number | 880.5445 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OKL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2717 |
| Device | Intravascular Administration Set, Automated Air Removal System |
| Product Code | OKL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set, Automated Air Removal System. |
| CFR Regulation Number | 880.5445 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANESTHESIA SAFETY PRODUCTS, LLC | ||
GRANTED | 1 | |