| Device Type ID | 64 |
| Device Name | Catheter, Nasal, Oxygen |
| Regulation Description | Nasal Oxygen Catheter. |
| 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 | 868.5350 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BZB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 64 |
| Device | Catheter, Nasal, Oxygen |
| Product Code | BZB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nasal Oxygen Catheter. |
| CFR Regulation Number | 868.5350 [🔎] |
| Device Problems | |
|---|---|
Defective Device | 8 |
Inflation Problem | 5 |
Sparking | 2 |
Flare Or Flash | 2 |
Electrical /Electronic Property Problem | 2 |
Occlusion Within Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Packaging Problem | 1 |
Kinked | 1 |
Device Packaging Compromised | 1 |
| Total Device Problems | 24 |