Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Fresenius Kabi makes
Fresenius Kabi manufactures single-use tubing sets and components for electric infusion pumps, including administration lines like the Volumat™ Line, as well as bedside infusion systems such as the Ivenix Infusion System. Their portfolio also includes apheresis and autotransfusion systems, such as the AMICUS Separator and ALYX 2RBC-LR Kit, alongside blood storage and transfer containers like the Fenwal Transfer Pack and Twin Transfer Set. The company produces infusion pump software for medication dosage applications and specialized blood component processing kits.
These devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with submissions documented through 510(k) clearances and Unique Device Identifiers (UDIs). The products are listed in the FDA’s regulatory databases, and the company operates with a US headquarters.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (216)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Agilia Link 8 Us | Z078135 | FDA UDI | Class II | Active |
| Vigilant Drug'Lib AGILIA US | 1.3 | FDA UDI | Class II | Active |
| ATF 120 Fast Start Kit | 9108504 | FDA UDI | Class II | Active |
| Agilia Usb Cable Us | Z073550 | FDA UDI | Class II | Active |
| Transfer Set | 2 D/X | FDA UDI | Class I | Active |
| Agilia Link 6 Us | Z076135 | FDA UDI | Class II | Active |
| Volumat™ Line | VL PA 92-2 | FDA UDI | Class II | Active |
| Agilia Link 4 Us | Z074135 | FDA UDI | Class II | Active |
| ATR 120 Autotransfusion Reservoir | 9108474 | FDA UDI | Class II | Active |
| Twin Transfer Set | 1 D/X | FDA UDI | Class I | Active |
| Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and Luer Adapter | 4C2161 | FDA UDI | Class II | Active |
| Bone Marrow Collection Stand | X6R2105 | FDA UDI | Class II | Active |
| Ivenix, Inc. | BKT-0004 | FDA UDI | Class II | Active |
| Twin Transfer Set | 9 D | FDA UDI | Class I | Active |
| Waste bag 10 l | 9006284 | FDA UDI | Class II | Active |
| Aurora Xi | Software Version 2.0 | FDA UDI | Class II | Active |
| Ivenix Infusion System | 030-0027-07 | FDA UDI | Class II | Active |
| AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector | X6R2302 | FDA UDI | Class II | Active |
| COMPOGUARD Advance Data | 9029751 | FDA UDI | Class I | Active |
| Ivenix | SET-0030-1 | FDA UDI | Class II | Active |
| Agilia Vp Mc Wifi Us | Z019735 | FDA UDI | Class II | Active |
| CompoSeal Slim | 9029701 | FDA UDI | Class I | Active |
| AMICUS Separator | 6R4590TH-M | FDA UDI | Class II | Active |
| AT1 Autotransfusion Set | 9005104 | FDA UDI | Class II | Active |
| Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed | 4R2367 | FDA UDI | Class II | Active |
| Glycerolyte 57 Solution | 4A7833 | FDA UDI | Class II | Active |
| Volumat™ Line | VL SP10-PE | FDA UDI | Class II | Active |
| Volumat™ Line | VL ON72-X1 | FDA UDI | Class II | Active |
| Volumat™ Line | VL TR 00-0 | FDA UDI | Class II | Active |
| Volumat™ Line | VL SP 22-0 | FDA UDI | Class II | Active |
| Vigilant Drug'Lib AGILIA US | 1.1 | FDA UDI | Class II | Active |
| Transfer Set | 4 D/X | FDA UDI | Class I | Active |
| Transfer Pack Container with Coupler - 2000 mL | 4R2041 | FDA UDI | Class II | Active |
| Sampling Site Coupler | 4C2405 | FDA UDI | Class I | Active |
| PLASMACELL Xi Disposable Set with SPIKESMART | 6R2600 | FDA UDI | Class II | Active |
| Volumat™ Line | VL SP 62-1 | FDA UDI | Class II | Active |
| AMICUS Separator Legacy Software | 6.1.51.0 | FDA UDI | Class II | Active |
| CompoGuard Basic (NA) | 9029641 | FDA UDI | Class I | Active |
| Fenwal Transfer Pack Container 300 mL with Coupler | 4R2014 | FDA UDI | Class II | Active |
| Alyx Rbc/Plasma Kit | X4R5700 | FDA UDI | Class II | Active |
| Plasmalink Bottle 1000 mL with locking luer adapter | 7R2069 | FDA UDI | Class II | Active |
| COMPOGUARD Advance Basic | 9029741 | FDA UDI | Class I | Active |
| Ivenix Infusion System | 030-0028-06 | FDA UDI | Class II | Unknown |
| Fenwal Plasma Extractor | 4R4414 | FDA UDI | Class I | Active |
| Fenwal Blood Comp. Recipient Set with Std. Blood Filter with Luer Adapter | 4C2160 | FDA UDI | Class II | Active |
| Ivenix, Inc. | 2.0 | FDA UDI | Class II | Unknown |
| AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly | 4R2354G | FDA UDI | Class II | Active |
| AMICUS Exchange Kit - Therapeutics | X6R2349 | FDA UDI | U | Active |
| Adaptive Nomogram Transfer Pack | 7R2090 | FDA UDI | Class II | Active |
| Adaptive Nomogram Bottle | 7R2071 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Fresenius Kabi has five FDA recall records initiated between March 29, 2010, and April 19, 2011, all of which are recorded as terminated. The reasons cited include potential deviations in patient hematocrit levels post-treatment, updates to the operating manual of the AS 104 Blood Cell Separator to remove references to specific blood set types, and issues with the AT1 Autotransfusion Set and CATS Continuous Autotransfusion device combination resulting in insufficient suction and triggering an alarm.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 19, 2011 | Z-2199-2011 | — | terminated | Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011. |
| Oct 18, 2010 | Z-0616-2011 | — | terminated | Potential for patient hematocrit dropped to levels lower than expected post-treatment. |
| Mar 29, 2010 | Z-0341-2011 | — | terminated | Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode. |
| Mar 29, 2010 | Z-0342-2011 | — | terminated | Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode. |
| Mar 29, 2010 | Z-0340-2011 | — | terminated | Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode. |