FDA device listing
AMICUS Exchange Kit - Therapeutics,AMICUS Separator System,Blood Component Filter Set with Vented Spike and Luer…
FDA device listing 1490823893 · Fresenius Kabi AG
Key facts
| Proprietary names | AMICUS Exchange Kit - Therapeutics,AMICUS Separator System,Blood Component Filter Set with Vented Spike and Luer Adapter,Waste Transfer Set |
|---|---|
| Owner/operator | Fresenius Kabi AG |
| Owner/operator number | 9027285 |
| Premarket submissions | K180615 |
| Product codes | GKT, LKN |
| Device names | GKT - Separator, Automated, Blood Cell, Diagnostic, LKN - Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 864.9245, ORCA1.LKN |
| Review panels | Gastroenterology & Urology, Hematology |
| Registered establishments | FENWAL, INC., FENWAL INTERNATIONAL, INC., FRESENIUS KABI WARRENDALE |
| Establishment registrations | 9612051, 3004548776, 3005778453 |
| FEI numbers | 3002806457, 3004548776, 3005778453 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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