FDA device listing
Breath Tech Mask,MASK, GAS, ANESTHETIC,Soft-Aire Mask,Vent Mask,Vent Mask II,Westmed Anesthesia Masks
FDA device listing 1897602204 · SunMed Group Holdings, LLC dba AirLife
Key facts
| Proprietary names | Breath Tech Mask,MASK, GAS, ANESTHETIC,Soft-Aire Mask,Vent Mask,Vent Mask II,Westmed Anesthesia Masks |
|---|---|
| Owner/operator | SunMed Group Holdings, LLC dba AirLife |
| Owner/operator number | 10044795 |
| Product codes | BSJ |
| Device names | BSJ - Mask, Gas, Anesthetic |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5550 |
| Review panels | Anesthesiology |
| Registered establishments | AirLife Finland Oy, PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V., Shenzhen Vital Signs-KTL Medical Instrument Co Ltd, SunMed Group Holdings, LLC |
| Establishment registrations | 1314417, 8030673, 3010362947, 3010838917 |
| FEI numbers | 1314417, 3004213967, 3010362947, 3010838917 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Repackager/Relabeler, Specification Developer, 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