FDA device listing
TherOx DownStream Cartridge,TherOx DownStream Console,TherOx DownStream Console, Refurbished,TherOx SSO2 Catheter
FDA device listing 1010062364 · ZOLL Medical Corporation
Key facts
| Proprietary names | TherOx DownStream Cartridge,TherOx DownStream Console,TherOx DownStream Console, Refurbished,TherOx SSO2 Catheter |
|---|---|
| Owner/operator | ZOLL Medical Corporation |
| Owner/operator number | 1220908 |
| Premarket submissions | P170027 |
| Product codes | MWG |
| Device names | MWG - System, Oxygen, Aqueous |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MWG |
| Review panels | Cardiovascular |
| Registered establishments | ZOLL Circulation, Inc., ZOLL International Holding B.V. |
| Establishment registrations | 3010617000, 3029871637 |
| FEI numbers | 3003793491, 3029871637 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter |
| 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