FDA device listing
CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell,Reservoir
FDA device listing 1491961963 · TERUMO CORP.
Key facts
| Proprietary names | CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell,Reservoir |
|---|---|
| Owner/operator | TERUMO CORP. |
| Owner/operator number | 8010026 |
| Premarket submissions | K040210 |
| Product codes | DTZ |
| Device names | DTZ - Oxygenator, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4350 |
| Review panels | Cardiovascular |
| Registered establishments | ASHITAKA FACTORY OF TERUMO CORP., TERUMO CORP. |
| Establishment registrations | 8010026, 9681834 |
| FEI numbers | 2828, 3002808327 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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