Known Identifiers & Locations
FEI Numbers
3003319165
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0020-2020 |
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Reason: Reports of pressure relief manifold venting gas below the standard pressure.
|
2019-05-30 |
Terminated
|
View Details
|
| Z-0021-2020 |
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Reason: Reports of pressure relief manifold venting gas below the standard pressure.
|
2019-05-30 |
Terminated
|
View Details
|
| Z-0022-2020 |
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Reason: Reports of pressure relief manifold venting gas below the standard pressure.
|
2019-05-30 |
Terminated
|
View Details
|
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