| Device |
intravascular administration set, automated air removal system |
| Regulation Description |
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 Code | OKL |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5445
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
