| Device Type ID | 104 |
| Device Name | Valve, Non-rebreathing |
| Regulation Description | Nonrebreathing Valve. |
| 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) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CBP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 104 |
| Device | Valve, Non-rebreathing |
| Product Code | CBP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonrebreathing Valve. |
| CFR Regulation Number | 868.5870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HANGZHOU JINLIN MEDICAL APPLINACES CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERSURGICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE LIFEGUARD STORE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Labelling, Instructions For Use Or Training Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Dynarex Corporation | II | Jul-25-2014 |
| 2 | Lifeline First Aid LLC | II | Jul-06-2016 |