FDA device listing
BIONAIRE,HOLMES,NORTHERN COOL SPRAY HUMID,SUNBEAM
FDA device listing 1227977756 · SUNBEAM PRODUCTS, INC.
Key facts
| Proprietary names | BIONAIRE,HOLMES,NORTHERN COOL SPRAY HUMID,SUNBEAM |
|---|---|
| Owner/operator | SUNBEAM PRODUCTS, INC. |
| Owner/operator number | 9914033 |
| 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 | SUNBEAM PRODUCTS, INC. |
| Establishment registrations | 1043899, 3004668337 |
| FEI numbers | 1043899, 3004668337 |
| Establishment operations | Complaint File Establishment, 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