NOxBOXi Noxkit
Single-use connection kit for Bunnell Jet Ventilator
1manufacturer
7catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AOK Tooling Limited | Shen Zhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Vero Biotech Inc., United States |
|---|---|
| FDA product code | MRN |
| Device type | Apparatus, Nitric Oxide Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5165 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2026-06-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 40 °C |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LGENOXKIT-2-15 | In distribution | |
| LGENOXKIT-3-HFJV | In distribution | |
| LGENOXKIT-EMER | In distribution | |
| LGENOXKIT-1-10 | In distribution | |
| LGENOXBOX-ITEST | In distribution | |
| LGENOXKIT-3-22 | In distribution | |
| LGENOXKIT-2-12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| INOmax | Mallinckrodt Manufacturing LLC | 18 |
| Genosyl® | Vero Biotech Inc. | 17 |
| AeroNOx 2.0 Nitric Oxide Delivery Device | International Biomedical, Ltd. | 1 |
| AeroNOx Nitric Oxide Delivery Device | International Biomedical, Ltd. | 1 |
| Ulspira TS | Airgas Therapeutics LLC | 1 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-17 | Class II | Process control | Cassette did not meet an 1n-process flow criterion. | 2 cassettes | |
| 2021-09-09 | Class I | Process control | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). | 120 consoles (3 consoles affected) | |
| 2021-05-19 | Class I | Software design | Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field. | 465 units | 2023-10-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.