Noxbox Limited
Sittingbourne Kent, GB
NOXBOX LIMITED appears in FDA device records in Sittingbourne Kent, GB. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012796317 | 3012796317 | NOXBOX LIMITED | 1 Eurolink Gateway, Sittingbourne Kent ME10 3AG GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0028-2026 | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I | 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). | Class I | Open, Classified | |
| Z-0029-2026 | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I | 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. | Class I | Open, Classified | |
| Z-2544-2025 | NOxBOXi Nitric Oxide Delivery System | Replacement of the internal Sample Pump due to high failure rates. | Class II | Open, Classified | |
| Z-1667-2023 | NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain