FDA device listing
DIASAFEplusUS
FDA device listing 1180042780 · FRESENIUS MEDICAL CARE
Key facts
| Proprietary names | DIASAFEplusUS |
|---|---|
| Owner/operator | FRESENIUS MEDICAL CARE |
| Owner/operator number | 8010838 |
| Premarket submissions | K231534 |
| Product codes | FIP, FJK, KDI, NII |
| Device names | FIP - Subsystem, Water Purification, FJK - Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, KDI - Dialyzer, High Permeability With Or Without Sealed Dialysate System, NII - Disinfectant, Dialysate Delivery System |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5665, 876.5820, 876.5860 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH, GXO Logistics H France, Pabst Transport GmbH & Co. KG, TST GmbH |
| Establishment registrations | 9611823, 3016096143, 3035708507, 3043014136 |
| FEI numbers | 3002807005, 3016096143, 3035708507, 3043014136 |
| Establishment operations | Foreign Exporter, 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