| Device Type ID | 49 |
| Device Name | Mask, Oxygen |
| Regulation Description | Oxygen 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 | 868.5580 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BYG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 49 |
| Device | Mask, Oxygen |
| Product Code | BYG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Oxygen Mask. |
| CFR Regulation Number | 868.5580 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 48 |
Disconnection | 27 |
Connection Problem | 12 |
Inflation Problem | 9 |
Occlusion Within Device | 5 |
No Flow | 4 |
Decoupling | 4 |
Material Integrity Problem | 4 |
Kinked | 4 |
Detachment Of Device Component | 4 |
Leak / Splash | 3 |
Incorrect Device Or Component Shipped | 3 |
Partial Blockage | 2 |
Fitting Problem | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Air Leak | 2 |
Hole In Material | 2 |
Device Issue | 2 |
Loose Or Intermittent Connection | 2 |
Component Falling | 2 |
Restricted Flow Rate | 1 |
Material Rupture | 1 |
Failure To Disconnect | 1 |
Malposition Of Device | 1 |
Device Markings / Labelling Problem | 1 |
Packaging Problem | 1 |
Torn Material | 1 |
Noise, Audible | 1 |
Break | 1 |
Crack | 1 |
Split | 1 |
Loose | 1 |
Misconnection | 1 |
Defective Component | 1 |
Migration Or Expulsion Of Device | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Fire | 1 |
Material Split, Cut Or Torn | 1 |
Loss Of Or Failure To Bond | 1 |
Material Puncture / Hole | 1 |
Obstruction Of Flow | 1 |
Electromagnetic Compatibility Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 167 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConvaTec, Inc | II | May-24-2017 |
| 2 | Intersurgical Inc | II | Dec-07-2017 |
| 3 | Salter Labs | II | Jul-23-2014 |