FDA device listing
COMPOGUARD,COMPOGUARD ADVANCE,DONATIONMASTER ADVANCE SOFTWARE,DONATION MASTER NT,HEMOLIGHT PLUS
FDA device listing 1246119398 · Fresenius Kabi AG
Key facts
| Proprietary names | COMPOGUARD,COMPOGUARD ADVANCE,DONATIONMASTER ADVANCE SOFTWARE,DONATION MASTER NT,HEMOLIGHT PLUS |
|---|---|
| Owner/operator | Fresenius Kabi AG |
| Owner/operator number | 9027285 |
| Premarket submissions | BK040005 |
| Product codes | KSQ |
| Device names | KSQ - Device, Blood Mixing And Blood Weighing |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.9195 |
| Review panels | Hematology |
| Registered establishments | Clinico Medical Sp. z o.o., FENWAL, INC., FRESENIUS HEMOCARE GMBH |
| Establishment registrations | 3004548776, 3004634229, 3008810357 |
| FEI numbers | 3004548776, 3004634229, 3008810357 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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