FDA device listing
VentStar Oxylog 3000F, 2000p 150,VentStar Oxylog 3000F, 2000p 300,VentStar Oxylog 3000F, 2000p 5x,VentStar Oxylog 3000F…
FDA device listing 1450301912 · Draegerwerk AG & Co. KGaA
Key facts
| Proprietary names | VentStar Oxylog 3000F, 2000p 150,VentStar Oxylog 3000F, 2000p 300,VentStar Oxylog 3000F, 2000p 5x,VentStar Oxylog 3000F (P) 190 |
|---|---|
| Owner/operator | Draegerwerk AG & Co. KGaA |
| Owner/operator number | 8010046 |
| Premarket submissions | K062267 |
| Product codes | CBK |
| Device names | CBK - Ventilator, Continuous, Facility Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5895 |
| Review panels | Anesthesiology |
| Registered establishments | Draeger Interservices GmbH, Draegerwerk AG & Co. KGaA |
| Establishment registrations | 9611500 |
| FEI numbers | 3001104093 |
| Establishment operations | Contract 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