FDA device listing
BreathTech HME,CONDENSER, HEAT AND MOISTURE,Medline HME,Ventlab HME
FDA device listing 1565745302 · SunMed Group Holdings, LLC dba AirLife
Key facts
| Proprietary names | BreathTech HME,CONDENSER, HEAT AND MOISTURE,Medline HME,Ventlab HME |
|---|---|
| Owner/operator | SunMed Group Holdings, LLC dba AirLife |
| Owner/operator number | 10044795 |
| Product codes | BYD |
| Device names | BYD - Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5375 |
| Review panels | Anesthesiology |
| Registered establishments | AirLife Finland Oy, PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V., SunMed Group Holdings, LLC |
| Establishment registrations | 1314417, 8030673, 3010838917 |
| FEI numbers | 1314417, 3004213967, 3010838917 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, 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