FDA device listing
AFFINITY® NT Cardiotomy Venous Reservoir,AFFINITY® NT Hollow Fiber Oxygenator,AFFINITY® Venous Reservoir Bag,Capiox…
FDA device listing 2061545910 · Sotera Health LLC
Key facts
| Proprietary names | AFFINITY® NT Cardiotomy Venous Reservoir,AFFINITY® NT Hollow Fiber Oxygenator,AFFINITY® Venous Reservoir Bag,Capiox Flexible Venous Reservoir Bag CXFVR1500X,Capiox Flexible Venous Reservoir Bag CXFVR1500X Capiox Flexible Venous Reservoir Bag with X-coating,Capiox Flexible Venous Reservoir Bag CXFVR1500XC Capiox Flexible Venous Reservoir Bag with X-coating,CARDIOTOMY ADAPTER,INTERSEPT® Venous… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | DTN |
| Device names | DTN - Reservoir, Blood, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4400 |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 2029275 |
| FEI numbers | 1000306431 |
| Establishment operations | Contract Sterilizer |
| 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