FDA device listing
Vapotherm FELIX-1
FDA device listing 1469309190 · Primo Medical Group, Inc
Key facts
| Proprietary names | Vapotherm FELIX-1 |
|---|---|
| Owner/operator | Primo Medical Group, Inc |
| Owner/operator number | 9004401 |
| Product codes | CBD |
| Device names | CBD - Bottle, Collection, Breathing System (Calibrated) |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6740 |
| Review panels | General Hospital |
| Registered establishments | Primo Medical Group, Inc |
| Establishment registrations | 3009420598 |
| FEI numbers | 3009420598 |
| Establishment operations | Contract 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