Gambro Renal Products Inc

FDA Filings

This page includes the latest FDA filings for Gambro Renal Products Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9616240
FEI Number3002807196
NameGAMBRO DASCO S.P.A.
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVIA MODENESE,66
MEDOLLA Modena, 41036 IT
Establishment TypeManufacture Medical Device

Registration Number3003591774
FEI Number3003591774
NameThomas P Sampogna
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Baxter Parkway
Deerfield, IL 60015 US
Establishment TypeManufacture Medical Device

Registration Number9616023
FEI Number3002807039
NameThomas Sampogna
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Baxter Parkway
Deerfield, IL 60015 US
Establishment TypeManufacture Medical Device

Registration Number3007697864
FEI Number3007697864
NameGambro Rostock GmbH
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFriedrich Barnewitz-Str.3
Rostock Mecklenburg-Vorpommern, 18119 DE
Establishment TypeManufacture Medical Device

Registration Number3004367028
FEI Number3004367028
NameGAMBRO KATHETERTECHNIK HECHINGEN
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLINSENAECKER 1
HECHINGEN Baden-Wurttemberg, DE-72379 DE
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

Registration Number9610270
FEI Number3002807196
NameThomas Sampogna
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Baxter Parkway
Deerfield, IL 60015 US
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

Registration Number3003504604
FEI Number3003504604
NameGambro UF Solutions, Inc.
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7601 Northland Drive, Suite 170
Brooklyn Park, MN 55428 US
Establishment TypeManufacture Medical Device

Registration Number9611369
FEI Number3002807035
NameGAMBRO DIALYSATOREN GMBH
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressHOLGER - CRAFOORD - STRASSE 26
HECHINGEN Baden-Wurttemberg, 72379 DE
Establishment TypeManufacture Medical Device

Registration Number8030638
FEI Number3002806727
NameGAMBRO RENAL PRODUCTS S.A. DE C.V.
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBLVD PACIFICO 10014 PARQUE INDUSTRIAL PACIFICO
TIJUANA Baja California, CP 22643 MX
Establishment TypeManufacture Medical Device

Registration Number8010182
FEI Number3002807204
NameGAMBRO INDUSTRIES
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7, AV. LIONEL TERRAY, B.P. 126
MEYZIEU CEDEX Rhone, 69883 FR
Establishment TypeManufacture Medical Device

Registration Number3006552611
FEI Number3006552611
NameGambro Renal Products, Inc.
Owner & OperatorGambro Renal Products, Inc.
Contact AddressOne Baxter Parkway
Deerfield IL 60015 US
Official Correspondent
  • Thomas P Sampogna
  • 1-224-9483016-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1101 Jeter Avenue
Opelika, AL 36801 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Thomas Sampogna [Gambro Renal Products, Inc.]
Homechoice2020-04-01
Gambro UF Solutions, Inc. [Gambro Renal Products, Inc.]
PrisMax System Version 22019-09-06
GAMBRO RENAL PRODUCTS, INC.
 POLYFLUX REVACLEAR MAX 1106342019-05-30
GAMBRO RENAL PRODUCTS, INC.
 POLYFLUX REVACLEAR 1106332019-05-30
GAMBRO RENAL PRODUCTS, INC.
 REVACLEAR 114746L2018-07-06
GAMBRO RENAL PRODUCTS, INC.
 REVACLEAR 114745L2018-07-06
Gambro UF Solutions, Inc. [Gambro Renal Products, Inc.]
PrisMax2017-06-05
Thomas P Sampogna [Gambro Renal Products, Inc.]
PrismaSATE dialysis solutions2017-01-10
GAMBRO KATHETERTECHNIK HECHINGEN [Gambro Renal Products, Inc.]
Gamcath2015-10-27
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
Adsorba 300c2015-08-27
Thomas Sampogna [Gambro Renal Products, Inc.]
Prismaflex System 7.102014-12-22
GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]
Prismaflex System 7.102014-12-22
Gambro Rostock GmbH [Gambro Renal Products, Inc.]
XMARS2014-06-18
Gambro Rostock GmbH [Gambro Renal Products, Inc.]
Prismaflex System2014-06-18
Gambro Rostock GmbH [Gambro Renal Products, Inc.]
XMARS2014-06-18
Gambro Rostock GmbH [Gambro Renal Products, Inc.]
Prismaflex System2014-06-18
GAMBRO RENAL PRODUCTS, INC.
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT2014-03-26
GAMBRO RENAL PRODUCTS, INC.
PRISMAFLEX SYSTEM 7.102014-01-03
Gambro UF Solutions, Inc. [Gambro Renal Products, Inc.]
Sterile Bag2013-09-25
Gambro Renal Products, Inc.
Revaclear2013-05-07
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
Revaclear2013-05-07
GAMBRO RENAL PRODUCTS, INC.
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER2013-05-02
Gambro Rostock GmbH [Gambro Renal Products, Inc.]
Molecular Adsorbent Recirculating System (MARS)2012-12-17
GAMBRO RENAL PRODUCTS, INC.
MOLECULAR ADSORBENT RECIRCULATING(MARS)2012-12-14
Thomas P Sampogna [Gambro Renal Products, Inc.]
PRISMASATE2012-05-31
GAMBRO RENAL PRODUCTS, INC.
PRISMAFLEX2011-06-17
Thomas Sampogna [Gambro Renal Products, Inc.]
PRISMAFLEX MONITOR2011-06-17
GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]
PHOENIX MONITOR2011-05-25
GAMBRO RENAL PRODUCTS, INC.
PHOENIX HEMODIALYSIS DELIVERY SYSTEM2011-05-20
GAMBRO KATHETERTECHNIK HECHINGEN [Gambro Renal Products, Inc.]
GAMCATH HIGH FLOW CATHETER2010-12-28
GAMBRO RENAL PRODUCTS, INC.
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-1322010-12-21
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
CARTRIDGE BLOOD SET2010-11-04
GAMBRO RENAL PRODUCTS, INC.
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-5202010-11-03
GAMBRO RENAL PRODUCTS, INC.
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H2010-07-29
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
DIACLEAR2010-02-16
GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]
EXALIS2009-07-13
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
PRISMAFLEX M150 SET2008-10-07
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX M150 SET2008-10-07
GAMBRO RENAL PRODUCTS, INC.
PRISMAFLEX M150 SET2008-06-13
Thomas Sampogna [Gambro Renal Products, Inc.]
PRISMASATE2008-05-18
Thomas P Sampogna [Gambro Renal Products, Inc.]
PRISMASATE2008-05-18
GAMBRO DASCO S.P.A. [Gambro Renal Products, Inc.]
PHOENIX SYSTEM2008-05-18
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
GAMBRO CARTRIDGE BLOOD SETS2008-05-18
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX HEMODIALYZER MODEL 6H2008-05-18
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
PRISMAFLEX HF 1400 SET2008-05-18
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
PRISMAFLEX HF 1000 SET2008-05-18
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX HF 1400 SET2008-05-18
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX HF 1000 SET2008-05-18
Gambro Renal Products, Inc.
REVACLEAR2008-05-05
Gambro Renal Products, Inc.
REVACLEAR2007-12-13
GAMBRO RENAL PRODUCTS, INC.
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL2007-09-07
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 6LR, 8LR, 10LR2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 6L, 8L, 10L, 14L, 17L, 21L2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 17R, 21R, 24R2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 140H, 170H, 210H2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 11S, 14S, 17S, 21S, 24S2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 6LR, 8LR, 10LR2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 6L, 8L, 10L, 14L, 17L, 21L2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 17R, 21R, 24R2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 140H, 170H, 210H2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 11S, 14S, 17S, 21S, 24S2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 6LR, 8LR, 10LR2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 6L, 8L, 10L, 14L, 17L, 21L2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 17R, 21R, 24R2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 140H, 170H, 210H2007-03-21
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
POLYFLUX 11S, 14S, 17S, 21S, 24S2007-03-21
GAMBRO RENAL PRODUCTS, INC.
PRISMA M10 PRE SET2007-02-15
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX TPE 2000 SET2006-11-22
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMA TPE 2000 SET2006-11-22
Thomas Sampogna [Gambro Renal Products, Inc.]
HOSPAL BLOODLINES2006-11-22
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
ADSORBA2006-11-20
GAMBRO DIALYSATOREN GMBH [Gambro Renal Products, Inc.]
ADSORBA 150C2006-11-20
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
PRISMAFLEX MONITOR2006-04-06
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
PRISMAFLEX M60 SET2006-04-06
GAMBRO RENAL PRODUCTS S.A. DE C.V. [Gambro Renal Products, Inc.]
PRISMAFLEX M100 SET2006-04-06
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX MONITOR2006-04-06
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX M60 SET2006-04-06
GAMBRO INDUSTRIES [Gambro Renal Products, Inc.]
PRISMAFLEX M100 SET2006-04-06
Thomas P Sampogna [Gambro Renal Products, Inc.]
PRISMASATE2004-05-26
GAMBRO RENAL PRODUCTS, INC.
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE2004-05-24
Thomas Sampogna [Gambro Renal Products, Inc.]
BICART1999-08-31

Related Finance Registrations
NCAGE Code1S8T2GAMBRO RENAL PRODUCTS, INC.
CAGE Code1S8T2GAMBRO RENAL PRODUCTS, INC.
S.A.M. Registration1S8T2 [829042337]GAMBRO RENAL PRODUCTS, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092639421Barcelona ,Spain -> Long Beach, CaliforniaPAPER13 PKG
2020092656163Anvers,Belgium -> Savannah, GeorgiaTOP FILM ARTISET76 PCS
2020092352383Anvers,Belgium -> Savannah, GeorgiaTOP FILM ARTISET76 PCS
202009236626Anvers,Belgium -> Los Angeles, CaliforniaTOP FILM ARTISET1 PCS
2020092276172Anvers,Belgium -> Savannah, GeorgiaTOP FILM ARTISET76 PCS
202009173651Rotterdam,Netherlands -> Long Beach, CaliforniaTOP FILM ARTISET24 PCS
20200912507La Spezia,Italy -> Long Beach, CaliforniaFLEXIRENE MM 20 R8 PCS
2020091024189Anvers,Belgium -> Los Angeles, CaliforniaTOP FILM ARTISET1 PCS
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