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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
113915
In Commercial Distribution

  • 37332414108589 ()
  • 07332414108588 ()
113915

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
113914
In Commercial Distribution

  • 37332414108572 ()
  • 07332414108571 ()
113914

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
110411
In Commercial Distribution

  • 37332414100170 ()
  • 07332414100179 ()
110411S

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
107580
In Commercial Distribution

  • 37332414074648 ()
  • 07332414074647 ()
107580S

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
107501
In Commercial Distribution

  • 37332414074013 ()
  • 07332414074012 ()
107501S

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
105351
In Commercial Distribution

  • 37332414037049 ()
  • 07332414037048 ()
105351S

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
105353
In Commercial Distribution

  • 37332414037032 ()
  • 07332414037031 ()
105353S

  • Haemodialysis dialysate solution
dialysis solution,ml 500+1500 each
Mozarc Medical US LLC
MD042
In Commercial Distribution

  • 10884521807990 ()
  • 38051411600061 ()

  • Total Volume: 2000 Milliliter


  • Haemodialysis dialysate solution
No Description
NXSTAGE MEDICAL, INC.
RFP-205-WW
Not in Commercial Distribution

  • M535RFP205WW5 ()
  • M535RFP205WW0 ()


  • Haemodialysis dialysate solution
The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
BAXTER HEALTHCARE CORPORATION
955626
In Commercial Distribution

  • 00085412639499 ()
955626

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
7.21
Not in Commercial Distribution

  • 07332414126766 ()
955792

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
GAMBRO AB
7.20
In Commercial Distribution

  • 07332414124236 ()
955542

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
GAMBRO AB
7.XX
In Commercial Distribution

  • 07332414117702 ()
115269

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
5.XX
Not in Commercial Distribution

  • 07332414105266 ()
113081

  • Haemodialysis system, institutional
Med Aire Low Air Loss, 5"
Drive Devilbiss Healthcare
14025N
Not in Commercial Distribution

  • 00822383145884 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
Pressure PreventionGroup 1 Surfaces Product Description: Dlx APP w/Pad w/End Flaps,1/CV, 6/CT
Drive Devilbiss Healthcare
14001EFD
In Commercial Distribution

  • 00822383145457 ()
  • 50822383145452 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Variable Pressure Pump Only for 14001E
Drive Devilbiss Healthcare
14005E
In Commercial Distribution

  • 10822383140312 ()
  • 00822383140315 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
Pressure PreventionGroup 1 Surfaces Product Description: Prem.GuardGel/FoamOverlay42x76x3.5",1/cs
Drive Devilbiss Healthcare
14901
In Commercial Distribution

  • 00822383139449 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Standard,Fixed Pressure,1/ea,RTL
Drive Devilbiss Healthcare
14002E
In Commercial Distribution

  • 00822383135816 ()
  • 50822383135811 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
14001E
In Commercial Distribution

  • 00822383135809 ()
  • 50822383135804 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Pressure PreventionGroup 1 Surfaces Product Description: Mattress,Multi LayerFoam80x36,1/cs
Drive Devilbiss Healthcare
15019
In Commercial Distribution

  • 00822383125831 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
MedAireBariatricLowAirLoss,60"
Drive Devilbiss Healthcare
14060
In Commercial Distribution

  • 00822383118277 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
MedAireBariatricLowAirLoss,54"
Drive Devilbiss Healthcare
14054
In Commercial Distribution

  • 00822383118260 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
MedAireBariatricLowAirLoss,48"
Drive Devilbiss Healthcare
14048
In Commercial Distribution

  • 00822383118253 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
MedAire8"LowAirLoss.w/Defined
Drive Devilbiss Healthcare
14029DP
In Commercial Distribution

  • 00822383117164 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
MedAireBariatricLowAirLoss,10"
Drive Devilbiss Healthcare
14030
In Commercial Distribution

  • 00822383111605 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
MedAire8"LowAirLoss.w/Pump system
Drive Devilbiss Healthcare
14029
In Commercial Distribution

  • 00822383110820 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad, w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
14003-EF
In Commercial Distribution

  • 50822383110764 ()
  • 00822383110769 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Pressure PreventionGroup 1 Surfaces Product Description: Static.Air Mattress Overlay,1/bx
Drive Devilbiss Healthcare
14428
Not in Commercial Distribution

  • 00822383110257 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
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