FRESENIUS KABI WARRENDALE

FDA Device Registration & Listing · WARRENDALE, PA, US · Registration 3005778453

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005778453
FEI Number
3005778453
Entity Name
FRESENIUS KABI WARRENDALE
City/State/Country
WARRENDALE, PA, US
Establishment Address
770 Commonwealth Dr, WARRENDALE, PA 15086, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fresenius Kabi AG (Owner Number: 9027285)
Owner / Operator Contact Address
Else-Kroner-Str. 1, 61352 Bad Homburg, DE-NOTA NONE, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200530
PMA Number
N/A

All Registered Proprietary Names

ALYX 2RBC LR Kit with Saline Spike ALYX Component Collection System BONE MARROW COLLECTION KIT BONE MARROW COLLECTION STAND Amicus Apheresis Kit – Functionally Closed Single Needle with PAS Spike and Dual Plasma Containers AMICUS Separator AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike Amicus Apheresis Kit – Functionally Closed Double Needle with PAS Spike and Dual Plasma Containers AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike ALYX COMPONENT COLLECTION SYSTEM ALYX Component Collection System DXT AMICUS Separator System Alyx Component Collection System PLASMACELL Xi Disposable Set Aurora Xi Plasmapheresis System PLASMACELL-C DISPOSABLE SET AURORA PLASMAPHERESIS SYSTEM ALYX COMPONENT COLLECTION SYSTEM AMICUS SEPARATOR SYSTEM ALYX 2RBC-LR Kit ALYX 2RBC DISPOSABLE SET ALYX Component Collection System ALYX INSTRUMENT AMICUS Separator System Aurora Xi Plasmapheresis System Aurora Plasmapheresis System Software Version 2.1 Slide Clamp Plasma Extractor Phelix Photoactivation Device Aurora Plasmapheresis System Aurora Software Version 1.3 Upgrade Kit LAB EQUIPMENT Hand Sealer Hand Sealer Clip Aurora Xi Plasmapheresis System Software Version 2 ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC) ALYX PLASMA KIT AMICUS SEPARATOR SYSTEM ALYX Component Collection System ALYX 2 RBC-LR Kit ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX COMPONENT COLLECTION SYSTEM (6R5725) Ivenix Infusion System (IIS) Centerium Alyx Red Cell Kit LOVO Med Cell Processing System Alyx Component Collection System ALYX COMPONENT COLLECTION SYSTEM Bone Marrow Collection Kit Bone Marrow Collection Container Bone Marrow Collection Stand DXT Relay Alyx Cart Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters Bone Marrow Collection Stand AMICUS Separator System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2015-05-12
LWE Bone Marrow Collection/Transfusion Kit Unknown Class 2 N/A 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-05-12
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-15
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-10-17
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-12-14
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2016-12-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-04-26
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-09-27
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2019-12-09
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2019-12-09
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-10-12
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2019-10-04
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2014-11-05
LNR System, Photopheresis, Extracorporeal Unknown Class 3 N/A 2019-12-09
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-02
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2014-10-17
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2025-02-04
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-15
FRN Pump, Infusion General Hospital Class 2 880.5725 2022-05-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-04
PHC Infusion Safety Management Software General Hospital Class 2 880.5725 2022-05-04
PHC Infusion Safety Management Software General Hospital Class 2 880.5725 2018-06-22
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2018-05-24
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2019-07-25
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-15
LWE Bone Marrow Collection/Transfusion Kit Unknown Class 2 N/A 2016-07-11
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2014-10-15
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2014-10-17
LWE Bone Marrow Collection/Transfusion Kit Unknown Class 2 N/A 2017-08-15
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2020-09-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2020-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Kabi AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014732157 Fresenius Kabi USA, LLC North Andover, MA, US
3004634229 FRESENIUS HEMOCARE GMBH Friedberg Hesse, DE
9611902 Fenwal France S.A.S. Lacs Indre, FR
9681819 FRESENIUS KABI DEUTSCHLAND GMBH BAD HERSFELD Hesse, DE
3008810357 Clinico Medical Sp. z o.o. Blonie/Miekinia Dolnoslaskie, PL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30
K840616 Advanced Bio Systems, Inc. MINI-PUMP U-100 1984-03-30
K850183 Deltec Systems, Inc. CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M 1985-03-13
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0001-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025 Zyno Medical LLC 2
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005778453. Last updated year: 2026. Please use registration number 3005778453 when referencing this establishment in official correspondence.
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