FDA device listing
Theranova Dialyzers (Theranova 400, Theranova 500)
FDA device listing 1619075872 · Vantive US Healthcare LLC
Key facts
| Proprietary names | Theranova Dialyzers (Theranova 400, Theranova 500) |
|---|---|
| Owner/operator | Vantive US Healthcare LLC |
| Owner/operator number | 9038727 |
| Premarket submissions | DEN190042 |
| Product codes | QAX |
| Device names | QAX - Hemodialyzer With Expanded Solute Removal Profile |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5862 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | GAMBRO DIALYSATOREN GMBH, Vantive US Healthcare LLC |
| Establishment registrations | 9611369, 3038195011 |
| FEI numbers | 3002807035, 3038195011 |
| Establishment operations | Complaint File Establishment, 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