FDA device listing
ResOne Humidifier Bottle
FDA device listing 2008227050 · Doner Industries, Inc.
Key facts
| Proprietary names | ResOne Humidifier Bottle |
|---|---|
| Owner/operator | Doner Industries, Inc. |
| Owner/operator number | 10083072 |
| Product codes | KFZ |
| Device names | KFZ - Humidifier, Non-Direct Patient Interface (Home-Use) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5460 |
| Review panels | Anesthesiology |
| Registered establishments | Doner Industries, Inc. |
| Establishment registrations | 3020751316 |
| FEI numbers | 3020751316 |
| Establishment operations | Specification Developer |
| 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