FDA device listing
INOMAX DS DELIVERY SYSTEM
FDA device listing 1877404729 · Mallinckrodt Hospital Products IP Limited
Key facts
| Proprietary names | INOMAX DS DELIVERY SYSTEM |
|---|---|
| Owner/operator | Mallinckrodt Hospital Products IP Limited |
| Owner/operator number | 10050702 |
| Premarket submissions | K092545 |
| Product codes | MRN, MRO, MRP, MRQ |
| Device names | MRN - Apparatus, Nitric Oxide Delivery, MRO - Apparatus, Nitric Oxide, Backup Delivery, MRP - Analyzer, Nitric Oxide, MRQ - Analyzer, Nitrogen Dioxide |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.2380, 868.2385, 868.5165 |
| Review panels | Anesthesiology |
| Registered establishments | Mallinckrodt Manufacturing LLC |
| Establishment registrations | 3004531588 |
| FEI numbers | 3004531588 |
| Establishment operations | Manufacturer, Remanufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database