AeroNOx 2.0 Nitric Oxide Delivery Device
AeroNOx 2.0 delivers a controlled flow of nitric oxide into the inspiratory gas stream of a constant-flow ventilator or specified flow-inflating manual resuscitator. One enclosure contains…
AeroNOx 2.0 delivers a controlled flow of nitric oxide into the inspiratory gas stream of a constant-flow ventilator or specified flow-inflating manual resuscitator. One enclosure contains both delivery and gas-analysis components.
The analyzer samples inspiratory gas before it reaches the patient. Electrochemical cells measure nitric oxide and nitrogen dioxide, while a galvanic sensor measures oxygen and a pump draws the sample.
Backup Delivery Configurations
The AeroNOx Bagger can work with AeroNOx independently of the ventilator. The INOstat Bagger uses a fixed-output regulator to supply a constant nitric-oxide dose independently of both the ventilator and AeroNOx. These disposable, single-patient resuscitators provide different backup configurations.
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) | K193481 |
| Record published | 2021-06-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AeroNOx 2.0 | 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 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.