| Device Type ID | 52 |
| Device Name | Unit, Liquid-oxygen, Portable |
| Regulation Description | Portable Liquid Oxygen Unit. |
| 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) |
| CFR Regulation Number | 868.5655 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BYJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 52 |
| Device | Unit, Liquid-oxygen, Portable |
| Product Code | BYJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Portable Liquid Oxygen Unit. |
| CFR Regulation Number | 868.5655 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 33 |
Fluid Leak | 19 |
Leak / Splash | 8 |
Insufficient Information | 6 |
Appropriate Term/Code Not Available | 5 |
Device Operates Differently Than Expected | 5 |
Fire | 2 |
No Flow | 2 |
Use Of Device Problem | 1 |
Inadequate Service | 1 |
Device Operational Issue | 1 |
Gas Leak | 1 |
Infusion Or Flow Problem | 1 |
Inaccurate Flow Rate | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Improper Flow Or Infusion | 1 |
Break | 1 |
Filling Problem | 1 |
Moisture Damage | 1 |
Out-Of-Box Failure | 1 |
| Total Device Problems | 92 |