Automated Blood Cell Separators
Fresenius Kabi USA LLC.
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 |
Product Codes Associated With Registrations
PMA
PMN
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter
Fresenius Kabi USA LLC
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
AMICUS Separator System, AMICUS Separator System; Refurbished
FRESENIUS KABI USA LLC
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Blood Bank Supplies
Fresenius Kabi USA LLC.