FDA device listing
Filter CareStar 30,Filter CareStar 40A,Filter CareStar 45,Filter/HME TwinStar 25,Filter/HME TwinStar 55,Filter/HME…
FDA device listing 1387530229 · Draegerwerk AG & Co. KGaA
Key facts
| Proprietary names | Filter CareStar 30,Filter CareStar 40A,Filter CareStar 45,Filter/HME TwinStar 25,Filter/HME TwinStar 55,Filter/HME TwinStar 65A,Filter/HME TwinStar 8,Filter/HME TwinStar HEPA,Filter SafeStar 55,Filter SafeStar 60A,Filter SafeStar 80 |
|---|---|
| Owner/operator | Draegerwerk AG & Co. KGaA |
| Owner/operator number | 8010046 |
| Premarket submissions | K072002 |
| Product codes | CAH |
| Device names | CAH - Filter, Bacterial, Breathing-Circuit |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5260 |
| 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
- 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