FDA device listing
Salter Labs Nebulizer exhalation filter, 8980 series
FDA device listing 1346476732 · SunMed "also trading as AirLife"
Key facts
| Proprietary names | Salter Labs Nebulizer exhalation filter, 8980 series |
|---|---|
| Owner/operator | SunMed "also trading as AirLife" |
| Owner/operator number | 9038422 |
| Premarket submissions | K992986 |
| Product codes | CAF |
| Device names | CAF - Nebulizer (Direct Patient Interface) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5630 |
| Review panels | Anesthesiology |
| Registered establishments | Salter Labs, Salter Labs de Mexico de S.A. de C.V. |
| Establishment registrations | 3004748541, 3010272829 |
| FEI numbers | 3004748541, 3010272829 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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