Fresenius Hemocare G M B H

FDA Filings

This page includes the latest FDA filings for Fresenius Hemocare G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004634229
• FEI Number: 3004634229
• Name: FRESENIUS HEMOCARE GMBH
• Owner & Operator: Fresenius Kabi AG
• Contact Address: - ; 61346 Bad Homburg DE-NOTA NONE DE
• US Agent:
  • Cheryl Roscher
  • Fresenius Kabi USA, LLC
  • 847 5507909
  • 847 5502960
  • cheryl.roscher@fresenius-kabi.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Gruener Weg 10 ; Friedberg Hessen, D-61169 DE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K192368 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	CATSmart	2020-01-24
PMN K180831 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	CATSmart	2020-01-24
PMN K160735 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	CATSmart System	2016-09-22
PMN BK110012 | KSS FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COMPOMAT G5 AND COMPOMASTER NET G5 SYSTEM	2013-04-10
PMN BK950035 | KSS FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COMPOCOOL	2007-11-29
PMN BK040076 | KSB FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COMPODOCK	2007-11-16
PMN BK040005 | KSQ FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	HEMOLIGHT PLUS	2007-11-16
PMN BK040005 | KSQ FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	DONATION MASTER NT	2007-11-16
PMN BK040005 | KSQ FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COMPOGUARD	2007-11-16
PMN BK030022 | KSS FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COMPOMAT G4	2007-11-16
PMN BK030022 | KSS FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COMPOMASTER NT	2007-11-16
GHY FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	HemoSeal	2007-11-16
GHY FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	Composeal Universal	2007-11-16
GHY FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	Composeal Mobilea	2007-11-16
GHY FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	CompoSeal Mobilea II	2007-11-16
PMN K961706 | LKN FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	P1R PLASMA TREATMENT SET	2007-10-26
PMN K961706 | LKN FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	AS104	2007-10-26
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	Waste bag 10 L	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	Reinfusion Bag with Y-Adapter	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	Reinfusion Bag 1000 mL	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	Fresenius CATS Autotransfusion Syst	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	ATF 40 Fast Start Kit	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	ATF 120 Fast Start Kit	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	AT1 Autotransfusion Set	2007-10-19
PMN K060734 | LKN FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	TPE Plasma Exchange Set	2007-10-19
PMN K060734 | LKN FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	COM.TEC CELL SEPARATOR	2007-10-19
PMN K895435 | LKN FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	FRESENIUS CELL SEPARATION SYSTEM	2005-09-14
PMN K012178 | CAC FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]	FRESENIUS CATS AUT	2005-09-14

Related Finance Registrations

NCAGE Code	C6619	FRESENIUS HEMOCARE GMBH
CAGE Code	C6619	FRESENIUS HEMOCARE GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009231109	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
202009192153	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
202009181824	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
202009113386	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
202009026570	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
202008289411	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
2020082216615	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG
2020082027200	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .	1 PKG