FDA device listing
Bionaire humidifier,Claritin humidifier,Holmes humidifier,HoMedics humidifier,Humidifier,Mainstays humidifier…
FDA device listing 1322708160 · Zhangzhou iHastek Inc.
Key facts
| Proprietary names | Bionaire humidifier,Claritin humidifier,Holmes humidifier,HoMedics humidifier,Humidifier,Mainstays humidifier, HU00-19013B, HU00-19054, H12-01,Sunbeam humidifier,Therapure humidifier |
|---|---|
| Owner/operator | Zhangzhou iHastek Inc. |
| Owner/operator number | 10042566 |
| 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 | Zhangzhou iHastek Inc. |
| Establishment registrations | 3010186069 |
| FEI numbers | 3010186069 |
| 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