FDA device listing
Portex,UniPerc Adjustable Flange Tracheostomy Tube,UniPerc PDT Kit,UniPerc Percutaneous Dilation Tracheostomy Kit
FDA device listing 1195730392 · ICU Medical, Inc.
Key facts
| Proprietary names | Portex,UniPerc Adjustable Flange Tracheostomy Tube,UniPerc PDT Kit,UniPerc Percutaneous Dilation Tracheostomy Kit |
|---|---|
| Owner/operator | ICU Medical, Inc. |
| Owner/operator number | 8020727 |
| Premarket submissions | K083031 |
| Product codes | BTO |
| Device names | BTO - Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5800 |
| Review panels | Anesthesiology |
| Registered establishments | ICU Medical Healthcare Manufacturing S.A. de C.V., ICU Medical Nederland B.V. |
| Establishment registrations | 9617604, 3012542015 |
| FEI numbers | 3002558692, 3012542015 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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