FDA device listing
Bougie,Introducer,Portex,Portex Respiratory Stylets (IFE)
FDA device listing 1721728399 · ICU Medical, Inc.
Key facts
| Proprietary names | Bougie,Introducer,Portex,Portex Respiratory Stylets (IFE) |
|---|---|
| Owner/operator | ICU Medical, Inc. |
| Owner/operator number | 8020727 |
| Product codes | BSR |
| Device names | BSR - Stylet, Tracheal Tube |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5790 |
| Review panels | Anesthesiology |
| Registered establishments | ICU Medical Healthcare Manufacturing S.A. de C.V. |
| Establishment registrations | 9616567, 9617604 |
| FEI numbers | 3002558692, 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