Gambro Renal Products, Inc.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• baxter.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

  2014-03-26

  GAMBRO RENAL PRODUCTS, INC.

• PRISMAFLEX SYSTEM 7.10

  2014-01-03

  GAMBRO RENAL PRODUCTS, INC.

• REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

  2013-05-02

  GAMBRO RENAL PRODUCTS, INC.

• MOLECULAR ADSORBENT RECIRCULATING(MARS)

  2012-12-14

  GAMBRO RENAL PRODUCTS, INC.

• PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

  2012-05-25

  GAMBRO RENAL PRODUCTS

• PRISMAFLEX

  2011-06-17

  GAMBRO RENAL PRODUCTS, INC.

• PHOENIX HEMODIALYSIS DELIVERY SYSTEM

  2011-05-20

  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-132

  2010-12-21

  GAMBRO RENAL PRODUCTS, INC.

• GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

  2010-11-03

  GAMBRO RENAL PRODUCTS, INC.

• GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

  2010-07-29

  GAMBRO RENAL PRODUCTS, INC.

• PRISMAFLEX M150 SET

  2008-06-13

  GAMBRO RENAL PRODUCTS, INC.

• PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

  2008-02-04

  GAMBRO RENAL PRODUCTS

• GAMBRO CARTRIDGE BLOOD SETS

  2007-10-12

  GAMBRO RENAL PRODUCTS

• GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

  2007-09-07

  GAMBRO RENAL PRODUCTS, INC.

• PRISMA M10 PRE SET

  2007-02-15

  GAMBRO RENAL PRODUCTS, INC.

• GAMBRO QUICKSET BLOODLINES

  2007-01-30

  GAMBRO RENAL PRODUCTS

• PRISMA SYSTEM R03.10A

  2006-10-18

  GAMBRO RENAL PRODUCTS

• GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

  2006-04-24

  GAMBRO RENAL PRODUCTS

• GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

  2005-12-09

  GAMBRO RENAL PRODUCTS

• POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

  2005-05-27

  GAMBRO RENAL PRODUCTS

• MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

  2005-05-27

  GAMBRO RENAL PRODUCTS

• WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

  2005-03-09

  GAMBRO RENAL PRODUCTS

• GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

  2005-01-06

  GAMBRO RENAL PRODUCTS

• GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A

  2004-11-01

  GAMBRO RENAL PRODUCTS

• GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS

  2004-10-07

  GAMBRO RENAL PRODUCTS

• POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE

  2004-05-24

  GAMBRO RENAL PRODUCTS, INC.

• GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

  2003-05-06

  GAMBRO RENAL PRODUCTS

• PRISMA SYSTEM

  2002-08-06

  GAMBRO RENAL PRODUCTS

• PRISMASATE

  2002-01-15

  GAMBRO RENAL PRODUCTS

• BICART

  2002-01-08

  GAMBRO RENAL PRODUCTS

• DIACLEAR ULTRAFILTER

  2001-11-01

  GAMBRO RENAL PRODUCTS

• PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

  2001-10-31

  Gambro Renal Products

• GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L

  2001-10-10

  GAMBRO RENAL PRODUCTS

• DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

  2001-08-02

  GAMBRO RENAL PRODUCTS

• GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R

  2001-06-04

  GAMBRO RENAL PRODUCTS

• PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET

  2000-07-07

  GAMBRO RENAL PRODUCTS

GUDID#

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used when a low extracorporeal blood volume is recommended.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• REVACLEAR - Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2018-01-15

• REVACLEAR - Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2017-02-08

• Recirculation Adapter/Priming Connector - This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. The 75 ml volume models are used when a low extracorporeal blood volume is recommended.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• POLYFLUX REVACLEAR - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2015-10-07

• POLYFLUX REVACLEAR MAX - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2015-10-07

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used when a low extracorporeal blood volume is recommended.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. The 75 ml volume models are used when a low extracorporeal blood volume is recommended.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Recirculation Adapter/Priming Connector - This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• Cartridge Blood Set - The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

  Gambro Renal Products, S.A. de C.V.

  2015-10-23

• POLYFLUX REVACLEAR MAX - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2015-10-07

• POLYFLUX REVACLEAR - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2015-10-07

• REVACLEAR - Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2018-01-15

• REVACLEAR - Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis

  GAMBRO RENAL PRODUCTS, INC.

  2017-02-08