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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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PrismaSATE - 07332414108601

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.
113917
In Commercial Distribution

  • 37332414108602 ()
  • 07332414108601 ()
113917

  • Haemodialysis dialysate solution

PrismaSATE - 07332414108595

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.
113916
In Commercial Distribution

  • 37332414108596 ()
  • 07332414108595 ()
113916

  • Haemodialysis dialysate solution

PrismaSATE - 07332414108588

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

PrismaSATE - 07332414108571

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

PrismaSATE - 07332414100179

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

PrismaSATE - 07332414074647

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

PrismaSATE - 07332414074012

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

PrismaSATE - 07332414066833

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.
106957
In Commercial Distribution

  • 37332414066834 ()
  • 07332414066833 ()
106957S

  • Haemodialysis dialysate solution

PrismaSATE - 07332414037048

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

PrismaSATE - 07332414037031

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

HMB32 - 38051411600351

dialysis solution,ml 500+4500
Mozarc Medical US LLC
MD088
In Commercial Distribution

  • 08051411600350 ()
  • 38051411600351 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution

NxStage PureFlow Solution - M535RFP205WW0

No Description
NXSTAGE MEDICAL, INC.
RFP-205-WW
Not in Commercial Distribution

  • M535RFP205WW5 ()
  • M535RFP205WW0 ()


  • Haemodialysis dialysate solution

HMB32 - 38051411600061

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

  • 10884521807990 ()
  • 38051411600061 ()

  • Total Volume: 2000 Milliliter


  • Haemodialysis dialysate solution

prisMaxPrisMax System - 00085412639499

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

Prismaflex - 07332414124236

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

Prismaflex - 07332414117702

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

PRISMAFLEX - 07332414126766

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

Prismaflex - 07332414105266

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

McKessan - 00612479258181

Pressure Prevention Group 1 Surfaces Product Description APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
146-14001E
In Commercial Distribution

  • 00612479258181 ()


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

Med Aire - 00822383145884

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

DRIVEMEDICAL - 00822383145457

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

Drive - 00822383140315

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

DRIVEMEDICAL - 00822383139449

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

DRIVEMEDICAL - 00822383135816

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

DRIVEMEDICAL - 00822383135809

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

Drive - 00822383125831

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

Med Aire - 00822383118277

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

Med Aire - 00822383118260

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

Med Aire - 00822383118253

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

Med Aire - 00822383117164

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
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