| Device Type ID | 16 |
| Device Name | Bag, Reservoir |
| Regulation Description | Reservoir Bag. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5320 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BTC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 16 |
| Device | Bag, Reservoir |
| Product Code | BTC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Reservoir Bag. |
| CFR Regulation Number | 868.5320 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 7 |
Disconnection | 3 |
Valve, Flow | 1 |
Fluid Leak | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical Europe Ltd | II | Apr-12-2018 |