Known Identifiers & Locations
FEI Numbers
3012796317
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 (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0028-2026 |
NOxBOXi Nitric Oxide Delivery System;
Model Numbers: NOXBOX-I
Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
|
2025-09-09 |
Open, Classified
|
View Details
|
| Z-0029-2026 |
NOxBOXi Nitric Oxide Delivery System;
Model Numbers: NOXBOX-I
Reason: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
|
2025-09-09 |
Open, Classified
|
View Details
|
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