Fresenius Kabi USA, LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014732157 | 3014732157 | Fresenius Kabi USA, LLC | 1 | N | 2026-01-01 | 50 High Street Suite 50 North Andover MA US 01845 |
| 1321116 | 3001833549 | Fresenius Kabi USA, LLC | 1 | N | 2020-04-25 | 3159 STALEY RD. GRAND ISLAND NY US 14072 |
| 3002733956 | 3002733956 | Fresenius Kabi USA, LLC | 1 | N | 2020-04-25 | 3 CORPORATE DR STE 300 Lake Zurich IL US 60047 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 305423 | 1366991501 | K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | FPA | 2021-11-10 |
| 305423 | 1202960113 | K183311 | Ivenix Infusion System (IIS) | FRN | 2019-06-07 |
| 17817 | 1916895131 | K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | NZW | 2010-06-18 |
| 17819 | 1916895131 | K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | NZW | 2010-06-18 |