Genosyl®
Gas Line Set with Integrated Humidification Reservoir
1manufacturer
17catalogue 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 | 2023-10-06 |
| Record revised | 2024-09-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 57 to 110 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH |
| Packaging | With quick connect, without quick conn |
| Sizes | Width 40.6 cm |
| Distribution end date | 2026-05-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 601970-01 | In distribution | |
| 602166-01 | In distribution | |
| 602001-01 | In distribution | |
| 602504-01 | In distribution | |
| 602489 | In distribution | |
| 600943-01 | In distribution | |
| 601747-01 | In distribution | |
| 601743-01 | In distribution | |
| 602490-02 | In distribution | |
| 601445-01 | In distribution | |
| 601588 | Width 40.6 cm | In distribution |
| 601745-01 | In distribution | |
| 601823 | In distribution | |
| 601955 | In distribution | |
| 601503-01 | In distribution | |
| 602747-01 | Withdrawn | |
| 602716-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| INOmax | Mallinckrodt Manufacturing LLC | 18 |
| NOxBOXi Noxkit | Vero Biotech Inc. | 7 |
| 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Vero Biotech Inc. | UDI-DI | 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) |
Recalls
1 of these is 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 | |
| 2021-05-19 | 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.