FDA device listing
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE),Nebulizers Large Volume Prefilled And Dry
FDA device listing 1504714828 · SunMed Group Holdings, LLC dba AirLife
Key facts
| Proprietary names | HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE),Nebulizers Large Volume Prefilled And Dry |
|---|---|
| Owner/operator | SunMed Group Holdings, LLC dba AirLife |
| Owner/operator number | 10044795 |
| Premarket submissions | K853146 |
| Product codes | BTT |
| Device names | BTT - Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5450 |
| Review panels | Anesthesiology |
| Registered establishments | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V., SunMed Group Holdings, LLC, SUNMED GROUP HOLDINGS, LLC dba AirLife |
| Establishment registrations | 1314417, 8030673, 3030308442 |
| FEI numbers | 1314417, 3004213967, 3030308442 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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