FDA device listing
Normothermic preservation system for transplantation of initially unacceptable donor lungsNormothermic machine perfusion
FDA device listing 1625784337 · FRESENIUS KABI DEUTSCHLAND GMBH
Key facts
| Proprietary names | Normothermic preservation system for transplantation of initially unacceptable donor lungsNormothermic machine perfusion |
|---|---|
| Owner/operator | FRESENIUS KABI DEUTSCHLAND GMBH |
| Owner/operator number | 9097270 |
| Product codes | PHO, QBA |
| Device names | PHO - Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs, QBA - Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PHO, ORCA1.QBA |
| Review panels | Gastroenterology & Urology |
| Registered establishments | FRESENIUS KABI AUSTRIA GMBH |
| Establishment registrations | 3003708554 |
| FEI numbers | 3003708554 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer |
| 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