FDA device listing
PD Cycler Set with 1 Trigger,PD Cycler Set with 2 Triggers
FDA device listing 1727184474 · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Proprietary names | PD Cycler Set with 1 Trigger,PD Cycler Set with 2 Triggers |
|---|---|
| Owner/operator | Fresenius Medical Care Renal Therapies Group, LLC |
| Owner/operator number | 9030510 |
| Product codes | FKX |
| Device names | FKX - System, Peritoneal, Automatic Delivery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5630 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | ERIKA DE REYNOSA, S.A. DE C.V. |
| Establishment registrations | 8030665, 3015335038 |
| FEI numbers | 3002807744, 3015335038 |
| Establishment operations | 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