FDA device listing
Filtered HME,HME,Portex,THERMOVENT,THERMOVENT T - 15MM CONNECTOR HEAT & MOISTURE EXCHANGER, 50/CA
FDA device listing 1681285922 · ICU Medical, Inc.
Key facts
| Proprietary names | Filtered HME,HME,Portex,THERMOVENT,THERMOVENT T - 15MM CONNECTOR HEAT & MOISTURE EXCHANGER, 50/CA |
|---|---|
| Owner/operator | ICU Medical, Inc. |
| Owner/operator number | 8020727 |
| Product codes | BYD |
| Device names | BYD - Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5375 |
| 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