Fresenius Hemocare Netherlands B V

FDA Filings

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

FDA Registration(s)

• Registration Number: 9610969
• FEI Number: 3002807758
• Name: FRESENIUS HEMOCARE NETHERLANDS B.V.
• Owner & Operator: Fresenius Kabi AG
• Contact Address: - ; 61346 Bad Homburg DE-NOTA NONE DE
• US Agent:
  • Cheryl Roscher
  • Fresenius Kabi LLC
  • 847 5507909
  • cheryl.roscher@fresenius-kabi.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: RUNDE ZZ 41 ; EMMER-COMPASCUUM Drenthe, NL-7881 HM NL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K192368 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	CATSmart	2020-01-24
PMN K180831 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	CATSmart	2020-01-24
PMN K160735 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	CATSmart System	2016-09-22
PMN K984233 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATY-Y ADAPTER	2011-04-29
PMN K984233 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATS SUCTION LINE	2011-04-29
PMN K984233 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATO OXYGENATOR LINE	2011-04-29
PMN K971274 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	PSQ PLASMA SEQUESTRATION SET	2011-04-29
PMN BK880007 | GKT FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	C4L PLATELET SET	2011-04-29
PMN BK880007 | GKT FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	C4 PLATELET SET	2011-04-29
PMN K961706 | LKN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	P1R PLASMA TREATMENT SET	2007-10-26
PMN K961706 | LKN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	AS104	2007-10-26
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	Waste bag 10 L	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	Reinfusion Bag with Y-Adapter	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	Reinfusion Bag 1000 mL	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	Fresenius CATS Autotransfusion Syst	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATF 40 Fast Start Kit	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATF 120 Fast Start Kit	2007-10-19
PMN K960006 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	AT1 Autotransfusion Set	2007-10-19
PMN K060734 | LKN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	TPE Plasma Exchange Set	2007-10-19
PMN K060734 | LKN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	COM.TEC CELL SEPARATOR	2007-10-19
PMN K984586 | DTN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	FRESENIUS CATS AUT	2005-09-14
PMN K984586 | DTN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATR40	2005-09-14
PMN K984586 | DTN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATR120	2005-09-14
PMN K984586 | DTN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	ATR Cap Set	2005-09-14
PMN K895435 | LKN FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	FRESENIUS CELL SEPARATION SYSTEM	2005-09-14
PMN K012178 | CAC FRESENIUS HEMOCARE NETHERLANDS B.V. [Fresenius Kabi AG]	FRESENIUS CATS AUT	2005-09-14

Related Finance Registrations

NCAGE Code	H0V81	FRESENIUS HEMOCARE NETHERLANDS B.V.
CAGE Code	H0V81	FRESENIUS HEMOCARE NETHERLANDS B.V.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020050227987	Rotterdam,Netherlands -> Philadelphia, Pennsylvania	TRANSFUSION EQUIPMENT HS CODE 90189050 FREIGHT PREPAID ONCARRIAGE TO TORONTO PREPAID DESTINATION THC PREPAID	7 PCS
20200414148	South Riding Point,Bahamas -> Port Everglades, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - TRANSFUSION EQUIPMENT	39 PKG
20200414148	South Riding Point,Bahamas -> Port Everglades, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - TRANSFUSION EQUIPMENT FREIGHT PREPAID	39 PKG
202001316166	Rotterdam,Netherlands -> Savannah, Georgia	OF MEDICAL EQUIPMENT LOADED ON 20 PALLETS TEMPERATURE SETTING TEMP PLUS 18 DGR CELSIUS HS-CODE(S) 90189050 BANQRTM2281194	400 CTN
202001316178	Rotterdam,Netherlands -> Savannah, Georgia	OF MEDICAL EQUIPMENT LOADED ON 20 PALLETS TEMPERATURE SETTING TEMP PLUS 18 DGR CELSIUS HS-CODE(S) 90189050 BANQRTM2281197	400 CTN
202001316156	Rotterdam,Netherlands -> Savannah, Georgia	OF MEDICAL EQUIPMENT LOADED ON 20 PALLETS TEMPERATURE SETTING TEMP PLUS 18 DGR CELSIUS HS-CODE 90189050 BANQRTM2281195	400 CTN
202001316176	Rotterdam,Netherlands -> Savannah, Georgia	OF MEDICAL EQUIPMENT LOADED ON 19 PALLETS TEMPERATURE SETTING TEMP PLUS 18 DGR CELSIUS HS-CODE 90189050 BANQRTM2281196	380 CTN
2020011515981	South Riding Point,Bahamas -> Port Everglades, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - TRANSFUSION EQUIPMENT	39 PKG
2020011515981	South Riding Point,Bahamas -> Port Everglades, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - TRANSFUSION EQUIPMENT FREIGHT PREPAID	39 PKG
2020010939170	Rotterdam,Netherlands -> Savannah, Georgia	OF MEDICAL EQUIPMENT LOADED ON 19 PALLETS TEMPERATURE SETTING TEMP PLUS 18 DGR CELSIUS HS-CODE 90189050 BANQRTM2280724	377 CTN