| Device Type ID | 138 |
| Device Name | Mask, Oxygen, Non-rebreathing |
| Regulation Description | Nonrebreathing Mask. |
| 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) Exempt |
| CFR Regulation Number | 868.5570 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KGB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 138 |
| Device | Mask, Oxygen, Non-rebreathing |
| Product Code | KGB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonrebreathing Mask. |
| CFR Regulation Number | 868.5570 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 26 |
Disconnection | 22 |
Connection Problem | 16 |
Inflation Problem | 10 |
Loose Or Intermittent Connection | 8 |
Break | 8 |
Defective Device | 6 |
Failure To Adhere Or Bond | 5 |
Device Damaged Prior To Use | 4 |
Hole In Material | 4 |
Leak / Splash | 3 |
Burst Container Or Vessel | 3 |
Patient-Device Incompatibility | 2 |
Fitting Problem | 2 |
Material Rupture | 2 |
Improper Flow Or Infusion | 1 |
Crack | 1 |
Material Too Rigid Or Stiff | 1 |
Defective Component | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Occlusion Within Device | 1 |
No Flow | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 129 |