AeroNOx Nitric Oxide Delivery Device
Nitric Oxide Delivery Device
1manufacturer
1catalogue number
2510(k) clearances naming this product 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 | International Biomedical, Ltd., United States |
|---|---|
| FDA product code | MRN |
| Device type | Apparatus, Nitric Oxide Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5165 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K093260 |
| Record published | 2016-09-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AeroNOx | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| INOmax | Mallinckrodt Manufacturing LLC | 18 |
| Genosyl® | Vero Biotech Inc. | 17 |
| NOxBOXi Noxkit | Vero Biotech Inc. | 7 |
| AeroNOx 2.0 Nitric Oxide Delivery Device | International Biomedical, Ltd. | 1 |
| Ulspira TS | Airgas Therapeutics LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193481 | 2020-03-10 |
| K093260 | 2009-12-16 |
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.