Lactulose
Lactulose
FRESENIUS KABI DEUTSCHLAND GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9681819 | 3000147578 | FRESENIUS KABI DEUTSCHLAND GMBH | 1 | N | 2026-01-01 | 5 ROBERT-KOCH-STRASSE BAD HERSFELD Hesse DE D-36251 |
| 3003708554 | 3003708554 | FRESENIUS KABI AUSTRIA GMBH | 1 | N | 2026-01-01 | HAFNERSTRASSE 36 GRAZ Steiermark AT A-8055 |
| 3005778453 | 3005778453 | FRESENIUS KABI WARRENDALE | 1 | N | 2026-01-01 | 770 Commonwealth Dr WARRENDALE PA US 15086 |
| 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 |
| 3002608066 | 3002608066 | FRESENIUS KABI NORGE AS | 1 | N | 2020-04-25 | Svinesundsveien 80 Halden Ostfold NO 1778 |
| 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 |
|---|---|---|---|---|---|
| 204355 | 1671507489 | P990009 | FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT | PMX | 1999-12-08 |
| 25806 | 1171800032 | P900056 | ROTABLATOR(R) | MCX | 1993-05-28 |
| 25806 | 1625784337 | P160013 | Organ Care System (OCS™) Lung System | QBA | 2018-03-22 |
| 179717 | 1687706715 | K871198 | BONE MARROW COLLECTION KIT AND STAND | LWE | 1987-11-06 |
| 16565 | 1961927749 | K221121 | Volumat Polyethylene I.V. Administration Set | FPA | 2023-06-16 |
| 16565 | 1809783663 | K220301 | Volumat Line | FPA | 2023-06-02 |
| 305423 | 1366991501 | K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | FPA | 2021-11-10 |
| 16565 | 1377032239 | K212445 | freeflex+ Transfer Adapter | LHI | 2022-06-01 |
| 25806 | 1537061547 | K211314 | OCS Lung Solution | MSB | 2021-07-29 |
| 179717 | 1251520254 | K200530 | AMICUS Separator System | GKT | 2020-09-11 |
| 179717 | 1666878956 | K192150 | AMICUS Separator System | LKN | 2019-11-13 |
| 305423 | 1202960113 | K183311 | Ivenix Infusion System (IIS) | FRN | 2019-06-07 |
| 179717 | 1202960113 | K183311 | Ivenix Infusion System (IIS) | FRN | 2019-06-07 |
| 179717 | 1490823893 | K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | LKN | 2018-12-04 |
| 16565 | 1461767317 | K162826 | Encore Neutral | FPA | 2017-06-15 |
| 179717 | 1436562947 | K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | GKT | 2016-11-23 |
| 25806 | 1885787035 | K121774 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS | MCW | 2012-09-13 |
| 16565 | 1053905989 | K121613 | AGILIA INFUSION SYSTEM | FRN | 2013-05-01 |
| 17819 | 1916895131 | K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | NZW | 2010-06-18 |
| 17817 | 1916895131 | K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | NZW | 2010-06-18 |
| 179717 | 1017542021 | BK241135 | |||
| 179717 | 1213698683 | BK230824 | |||
| 179717 | 1278008680 | BK220788 | |||
| 179717 | 1972462941 | BK200478 | |||
| 179717 | 1258638614 | BK190368 | |||
| 179717 | 2045242275 | BK190351 | |||
| 179717 | 1780700915 | BK180268 | |||
| 179717 | 1203598430 | BK170099 | |||
| 179717 | 1480667983 | BK170072 | |||
| 179717 | 1404717297 | BK170057 | |||
| 179717 | 1739744907 | BK170030 | |||
| 179717 | 1405681946 | BK170001 | |||
| 179717 | 1317190992 | BK160042 | |||
| 179717 | 1498870149 | BK160028 | |||
| 179717 | 1715764929 | BK160012 | |||
| 179717 | 1108663750 | BK150236 | |||
| 179717 | 1434141742 | BK130030 | |||
| 179717 | 1698986145 | BK130004 | |||
| 179717 | 1028566065 | BK120041 | |||
| 179717 | 2008876173 | BK110072 | |||
| 179717 | 1697370601 | BK110025 | |||
| 179717 | 1828293567 | BK100056 | |||
| 179717 | 1647926282 | BK090031 | |||
| 179717 | 1068354240 | BK080053 | |||
| 179717 | 1119448276 | BK080024 | |||
| 179717 | 1070618302 | BK030085 | |||
| 179717 | 1811238891 | BK020059 | |||
| 179717 | 1363736095 | BK020056 | |||
| 179717 | 1202258100 | BK010033 | |||
| 179717 | 1001207226 | ||||
| 25806 | 1107077680 | ||||
| 16565 | 1124205599 | ||||
| 25806 | 1171800032 | ||||
| 179717 | 1271993438 | ||||
| 179717 | 1352877130 | ||||
| 179717 | 1396656618 | ||||
| 179717 | 1474918278 | ||||
| 25806 | 1625784337 | ||||
| 179717 | 1642267481 | ||||
| 25806 | 1885787035 | ||||
| 179717 | 1963350318 |
Product Codes Associated With Registrations#
NDC#
Cleviprex
clevidipine
Gentamicin
GENTAMICIN SULFATE
Gentamicin
GENTAMICIN SULFATE
Gentamicin
GENTAMICIN SULFATE
Chloramphenicol Sodium Succinate
CHLORAMPHENICOL SODIUM SUCCINATE
Oxytocin
OXYTOCIN
Oxytocin
OXYTOCIN
Thiamine
THIAMINE HYDROCHLORIDE
Thiamine
THIAMINE HYDROCHLORIDE
Thiamine
THIAMINE HYDROCHLORIDE
Mannitol
MANNITOL
Chorionic Gonadotropin
Chorionic Gonadotropin
SODIUM ACETATE
SODIUM ACETATE
Cyanocobalamin
CYANOCOBALAMIN
Cyanocobalamin
CYANOCOBALAMIN
Heparin Sodium
HEPARIN SODIUM
Magnesium Sulfate
MAGNESIUM SULFATE HEPTAHYDRATE
Magnesium Sulfate
MAGNESIUM SULFATE HEPTAHYDRATE
Magnesium Sulfate
Magnesium Sulfate Heptahydrate
Sodium Bicarbonate
Sodium Bicarbonate
Sodium Chloride
Sodium Chloride
Sodium Bicarbonate
Sodium Bicarbonate
Sodium Chloride
Sodium Chloride
Sodium Chloride
Sodium Chloride
Sodium Chloride
Sodium Chloride
Sodium Chloride
Sodium Chloride
Doxorubicin Hydrochloride
DOXORUBICIN HYDROCHLORIDE
GEMCITABINE
GEMCITABINE
GEMCITABINE
GEMCITABINE
Cisplatin
CISPLATIN
Etoposide
ETOPOSIDE
magnesium sulfate
MAGNESIUM SULFATE HEPTAHYDRATE
magnesium sulfate
MAGNESIUM SULFATE HEPTAHYDRATE
magnesium sulfate
MAGNESIUM SULFATE HEPTAHYDRATE
Magnesium Sulfate in 5% Dextrose
Magnesium Sulfate Heptahydrate
Magnesium Sulfate in 5% Dextrose
Magnesium Sulfate Heptahydrate
Pentam 300
PENTAMIDINE ISETHIONATE
Fluorouracil
FLUOROURACIL
Fluorouracil
FLUOROURACIL
PMN#
Volumat Polyethylene I.V. Administration Set
Fresenius Kabi
Volumat Line
Fresenius Kabi
Freeflex+ Transfer Adapter
Fresenius Kabi AG
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
Fresenius Kabi AG
Vigilant Software Suite – Vigilant Master Med
Fresenius Kabi AG
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
Fresenius Kabi AG
CATSmart, Automated Blood Processing Autotransfusion System
Fresenius Kabi AG
AMICUS Separator System
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi AG
Empty Containers For The Collection & Processing Of Blood/Blood Components
Fresenius Kabi AG
Blood Bank Supplies
Fresenius Kabi AG
AMICUS Separator System
Fresenius Kabi AG
CATSmart
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi AG
Empty Containers For The Collection & Processing Of Blood/Blood Components
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Empty Containers For The Collection & Processing Of Blood/Blood Components
Fresenius Kabi AG
CATSmart
Fresenius Kabi AG
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter
Fresenius Kabi USA LLC
Processing Systems For Frozen Blood
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Automated Blood Cell Separators
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi AG
Kit, Bone Marrow Collection
Fresenius Kabi
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 AG
CATSmart
FRESENIUS KABI AG
Kit, Bone Marrow Collection
Fresenius Kabi
Automated Blood Cell Separators
Fresenius Kabi AG
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
Automated Blood Cell Separators
Fresenius Kabi USA LLC.
AGILIA INFUSION SYSTEM
FRESENIUS KABI AG
Blood Bank Supplies
Fresenius Kabi USA LLC.
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
FRESENIUS KABI DEUTSCHLAND GMBH
Applications#
GUDID#
Amicus Separator - The Amicus Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
2026-03-11
Amicus MNC Apheresis Kit - Double Needle - For Mononuclear Cell (MNC) Collection. For use with the Amicus Separator.
2026-02-03
Amicus MNC Apheresis Kit - Double Needle - For Mononuclear Cell (MNC) Collection. For use with the Amicus Separator.
2026-02-03
COMPOGUARD Advance Basic - Device, Blood Mixing and Weighing
2024-10-30
COMPOGUARD Advance Data - Device, Blood Mixing and Weighing
2024-10-29
COMPOGUARD Advance COMPLETE - Device, Blood Mixing and Weighing
2024-10-29
CompoGuard Basic (NA) - Device, Blood Mixing And Weighing
2022-11-10
CompoGuard Data (NA) - Device, Blood Mixing And Weighing
2022-11-10
CompoGuard Complete (NA) - Device, Blood Mixing and Weighing
2022-11-10
ALYX 2RBC LR KIT - For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX System.
2018-02-14
Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed - For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
2016-09-09
Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed - For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
2016-09-09
AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
2020-10-20
Fenwal AMICUS Single Needle Advanced Kit - For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
2016-09-02
Fenwal AMICUS Double Needle Advanced Kit - For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
2016-09-02
AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
2020-10-20
Fenwal AMICUS Apheresis Kit - Double Needle - For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
2016-09-09
Fenwal AMICUS Apheresis Kit - Single Needle - For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
2016-09-09
AMICUS Apheresis Kit – Single Needle - For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For use with the AMICUS Separator.
2025-11-03
Fenwal Hand Sealer - The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418.
2025-04-30
Ivenix Infusion System - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1)
2022-03-24
Ivenix Infusion System - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, Microbore (Qty 1)
2022-03-24
Ivenix Infusion System - LVP Primary Administration Set, Single-Inlet, Low-Sorbing, Microbore (Qty 1)
2022-03-24
Adaptive Nomogram Bottle - For the collection, storage, and shipment of plasma prior to fractionation. For the collection of blood components. Sterile fluid path.
2025-03-14
Adaptive Nomogram Bottle - For the collection, storage, and shipment of plasma prior to fractionation. For the collection of blood components. Sterile fluid path.
2025-03-14
Aurora Xi - Aurora Xi Plasmapheresis System with Software Version 2.1
2025-02-26
Aurora Xi - Aurora Xi Plasmapheresis System with Software Version 2.0
2025-02-26
Plasmalink Bottle 1000 mL with locking luer adapter - For the collection of blood components. Sterile Fluid Path
2025-01-15
Plasmalink Bottle 1000 mL with locking luer adapter - For the collection of blood components. Sterile Fluid Path
2025-01-15
Adaptive Nomogram Transfer Pack - For processing and/or storage of blood and blood components. Sterile Fluid Path
2024-12-12
Adaptive Nomogram Transfer Pack - For processing and/or storage of blood and blood components. Sterile Fluid Path
2024-12-12
Volumat™ Line - VL SP 22-0
2016-09-24
Volumat™ Line - VL PR 42-11
2016-09-24
Volumat™ Line - VL ST 02-0
2016-09-24
Volumat™ Line - VL PR 42-21
2016-09-24
Volumat™ Line - VL PA 92-2
2016-09-24
Volumat™ Line - VL PR 72-11
2016-09-24
Volumat™ Line - VL PR 42-12
2016-09-24
Volumat™ Line - VL PN 02-1
2016-09-24
Volumat™ Line - VL ON 72-1
2016-09-24