FDA device listing
Versette external catheter device; Qivi acute male external urine management
FDA device listing 1228067015 · Foshan King Wonder Hi-Tech Co.,LTD.
Key facts
| Proprietary names | Versette external catheter device; Qivi acute male external urine management |
|---|---|
| Owner/operator | Foshan King Wonder Hi-Tech Co.,LTD. |
| Owner/operator number | 10084460 |
| Product codes | PXU |
| Device names | PXU - Fluid Drainage Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | FOSHAN KING WONDER HI-TECH CO.,LTD. |
| Establishment registrations | 3022121576 |
| FEI numbers | 3022121576 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| 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