FDA device listing
AquinOx,First Breath,OXYGEN NASAL CANNULA,Portex,Portex Nasal Oxygen set (IFE)
FDA device listing 1457421664 · ICU Medical, Inc.
Key facts
| Proprietary names | AquinOx,First Breath,OXYGEN NASAL CANNULA,Portex,Portex Nasal Oxygen set (IFE) |
|---|---|
| Owner/operator | ICU Medical, Inc. |
| Owner/operator number | 8020727 |
| Product codes | CAT |
| Device names | CAT - Cannula, Nasal, Oxygen |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5340 |
| Review panels | Anesthesiology |
| Registered establishments | ICU Medical Healthcare Manufacturing S.A. de C.V. |
| Establishment registrations | 9616567 |
| FEI numbers | 3002963732 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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