INOmax
TEE, O2 Tubing Sample, NO Bushing BCG, CE 2797
1manufacturer
18catalogue numbers in this listing
4510(k) clearances naming this product code
6recalls 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 | Mallinckrodt Manufacturing LLC, United States |
|---|---|
| FDA product code | MRN |
| Device type | Apparatus, Nitric Oxide Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5165 |
| Establishment | Contract manufacturer, Remanufacturer, Manufacturer |
| 510(k) | K222930 |
| Record published | 2023-05-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 57 to 110 KiloPascal |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90844 | In distribution | |
| 91270 | In distribution | |
| 10107 | In distribution | |
| 50239 | In distribution | |
| 50312 | In distribution | |
| 91359 | In distribution | |
| 90845 | In distribution | |
| 50371 | In distribution | |
| 10022 | In distribution | |
| 10090 | In distribution | |
| 91351 | In distribution | |
| 10095 | In distribution | |
| 50280 | In distribution | |
| 90855 | In distribution | |
| 10006 | In distribution | |
| 50372 | In distribution | |
| 50370 | In distribution | |
| 10020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Genosyl® | Vero Biotech Inc. | 17 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242578 | 2025-01-03 |
| K222930 | 2023-12-06 |
| K211153 | 2023-04-20 |
| K200389 | 2020-06-17 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mallinckrodt Manufacturing LLC | 510(k) number | 2018-07-09 | Class II | Process control | INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the correct expiration date noted (11/2020). | 108 units | 2020-11-30 |
| Mallinckrodt Manufacturing LLC | 510(k) number | 2016-11-21 | Class II | Equipment maintenance | Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device. | 45 | 2017-12-20 |
| Mallinckrodt Manufacturing LLC | 510(k) number | 2014-10-17 | Class II | Process change control | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Mon | 9 | 2015-04-16 |
| Mallinckrodt Manufacturing LLC | 510(k) number | 2014-03-27 | Class II | Software Design Change | An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In | 22 | 2014-11-21 |
Recalls
1 of these is Class II. 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 |
|---|---|---|---|---|---|
| 2015-01-14 | Class II | Process change control | Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this conditio | 45 units | 2015-04-15 |
| 2010-11-30 | Not classified | Nonconforming Material/Component | Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent L | 2446 | 2012-05-29 |
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.