Novalung Ultimate Kit (U.S.) - F32000015
2026-05-15
Xenios AG
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3030191221 | 3030191221 | Xenios AG | 1 | N | 2026-01-01 | Ferdinand-Lassalle-Strasse 18 Reutlingen Baden-Wurttemberg DE 72770 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 321073 | 1959574465 | K232926 | Novalung ultimate kit (US) | QJZ | 2024-04-15 |
| 321073 | 1794668762 | K191407 | Novalung System | QJZ | 2020-02-21 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QJZ | 2 | 2024-04-15 |
GUDID#
Novalung System - The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support.
2020-12-17
Novalung System - The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support.
2020-12-17