Fresenius Kabi Warrendale

FDA Filings

This page includes the latest FDA filings for Fresenius Kabi Warrendale. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005778453
• FEI Number: 3005778453
• Name: FRESENIUS KABI WARRENDALE
• Owner & Operator: Fresenius Kabi AG
• Contact Address: - ; 61346 Bad Homburg DE-NOTA NONE DE
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 770 Commonwealth Dr ; WARRENDALE, PA 15086 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN K192150 | LKN FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Separator System	2019-12-09
PMN K192150 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Separator System	2019-12-09
LNR FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Phelix Photoactivation Device	2019-12-09
PMN BK190368 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Aurora Plasmapheresis System Software Version 2.1	2019-10-04
PMN BK190351 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Alyx Component Collection System	2019-07-25
PMN K180615 | LKN FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Waste Transfer Set	2018-12-20
PMN K180615 | LKN FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Blood Component Filter Set with Vented Spike and Luer Adapter	2018-12-20
PMN K180615 | LKN FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Separator System	2018-12-20
PMN K180615 | LKN FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Exchange Kit - Therapeutics	2018-12-20
PMN K180615 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Waste Transfer Set	2018-12-20
PMN K180615 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Blood Component Filter Set with Vented Spike and Luer Adapter	2018-12-20
PMN K180615 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Separator System	2018-12-20
PMN K180615 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Exchange Kit - Therapeutics	2018-12-20
PMN BK180268 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Aurora Xi Plasmapheresis System, Software Version 1.2	2018-11-29
PHC FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Centerium	2018-06-22
PMN BK170099 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Amicus Separator System	2018-01-02
PMN BK170072 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	DXT	2017-10-17
PMN BK170057 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Aurora Xi Plasmapheresis System	2017-10-12
PMN BK170030 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Bone Marrow Collection Stand	2017-08-15
PMN BK170030 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters	2017-08-15
PMN BK170001 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Alyx Component Collection System	2017-04-26
PMN K162462 | LKN FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Separator System	2016-12-14
PMN K162462 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS Separator System	2016-12-14
PMN BK160028 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	PLASMACELL Xi Disposable Set	2016-09-27
PMN BK160028 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Aurora Xi Plasmapheresis System	2016-09-27
PMN BK160012 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Aurora Software Version 1.3 Upgrade Kit	2016-08-02
PMN BK160012 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Aurora Plasmapheresis System	2016-08-02
PMN BK160042 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Bone Marrow Collection Stand	2016-07-11
PMN BK160042 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Bone Marrow Collection Kit	2016-07-11
PMN BK160042 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Bone Marrow Collection Container	2016-07-11
PMN BK150236 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX Component Collection System	2015-05-12
PMN BK150236 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX 2RBC LR Kit with Saline Spike	2015-05-12
KSS FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Slide Clamp	2014-11-05
KSS FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Sampling Site Coupler	2014-11-05
KSS FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Plasma Extractor	2014-11-05
KSS FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Hand Sealer	2014-11-05
KSS FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Hand Sealer Clip	2014-11-05
PMN BK130004 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM, 4R5707	2014-10-17
PMN BK130004 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC)	2014-10-17
PMN BK130004 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL)	2014-10-17
PMN BK130004 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL), 4R5725	2014-10-17
JQC FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	CENTRIFUGE BAG	2014-10-17
JQC FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Alyx Cart	2014-10-17
PMN K871198 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	BONE MARROW COLLECTION STAND	2014-10-16
PMN K871198 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	BONE MARROW COLLECTION KIT	2014-10-16
PMN BK130030 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX PLASMA KIT	2014-10-16
PMN BK130030 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC)	2014-10-16
PMN BK130030 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL)	2014-10-16
PMN BK120041 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS SEPARATOR SYSTEM	2014-10-16
PMN BK120041 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM	2014-10-16
PMN BK110072 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	PLASMACELL-C DISPOSABLE SET	2014-10-16
PMN BK110072 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AURORA PLASMAPHERESIS SYSTEM	2014-10-16
PMN BK030085 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	AMICUS SEPARATOR SYSTEM	2014-10-16
PMN BK030085 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX Component Collection System	2014-10-16
PMN BK030085 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX 2 RBC-LR Kit	2014-10-16
PMN BK020059 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX Component Collection System	2014-10-16
PMN BK020056 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX Component Collection System	2014-10-16
PMN BK020056 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX 2RBC DISPOSABLE SET	2014-10-16
PMN BK010033 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX INSTRUMENT	2014-10-16
PMN BK010033 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX Component Collection System	2014-10-16
PMN BK010033 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX 2RBC-LR Kit	2014-10-16
PMN BK010033 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX 2RBC DISPOSABLE SET	2014-10-16
PMN BK110025 | MMH FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	DXT Relay	2014-10-15
PMN BK100056 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM	2014-10-15
PMN BK090031 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Fenwal Bone Marrow Collection Kit with Accessories	2014-10-15
PMN BK090031 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	Bone Marrow Collection Kit and Stand	2014-10-15
PMN BK090031 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	BONE MARROW COLLECTION KIT WITH ACCESSORIES	2014-10-15
PMN BK090031 | LWE FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	BONE MARROW COLLECTION KIT W/ACCESSORIES	2014-10-15
PMN BK080053 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM	2014-10-15
PMN BK080024 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (6R5725)	2014-10-15
PMN BK080024 | GKT FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725)	2014-10-15
KSQ FRESENIUS KABI WARRENDALE [Fresenius Kabi AG]	FRESENIUS KABI DONOR TUBE STRIPPER	1999-06-01