FDA device listing
Sunset Humidifier
FDA device listing 1055394170 · Sunset Healthcare Solutions
Key facts
| Proprietary names | Sunset Humidifier |
|---|---|
| Owner/operator | Sunset Healthcare Solutions |
| Owner/operator number | 9106379 |
| 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 | Sunset Healthcare Solutions Central Warehouse, SUNSET HEALTHCARE SOLUTIONS Warehouse |
| Establishment registrations | 3010834934, 3021244152 |
| FEI numbers | 3010834934, 3021244152 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| 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