FDA device listing
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir,Affinity NT Oxygenator with Balance Biosurface and…
FDA device listing 1590617445 · Medtronic, Inc.
Key facts
| Proprietary names | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir,Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K241352 |
| Product codes | DTZ |
| Device names | DTZ - Oxygenator, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4350 |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Mexico S. de R.L. de CV, MEDTRONIC PERFUSION SYSTEMS |
| Establishment registrations | 2184009, 9617601 |
| FEI numbers | 1000116158, 3002534070 |
| Establishment operations | Manufacturer |
| 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