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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 - 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 - 07332414123093

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.
955415
In Commercial Distribution

  • 37332414123094 ()
  • 07332414123093 ()
955415

  • Haemodialysis dialysate solution

PrismaSATE - 07332414114787

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.
114725
In Commercial Distribution

  • 37332414114788 ()
  • 07332414114787 ()
114725

  • Haemodialysis dialysate solution

PrismaSATE - 07332414108625

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.
113919
In Commercial Distribution

  • 37332414108626 ()
  • 07332414108625 ()
113919

  • Haemodialysis dialysate solution

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 - 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

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

DRIVEMEDICAL - 00822383103747

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

McKessan - 00822383007489

Pressure Prevention Group 2 Surfaces Product Description Med Aire Low Air Loss, 8in 1/cs
Drive Devilbiss Healthcare
146-14027
In Commercial Distribution

  • 00822383007489 ()


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

drive - 00822383007434

Pressure Prevention Sales Samples Product Description 15670 Mini Mattress Sample, 1/EA
Drive Devilbiss Healthcare
15670M-MINI
In Commercial Distribution

  • 00822383007434 ()


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

drive - 00822383007427

Pressure Prevention Sales Samples Product Description 14360 Mini Mattress Sample, 1/EA
Drive Devilbiss Healthcare
14360M-MINI
In Commercial Distribution

  • 00822383007427 ()


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

drive - 00822383007410

Pressure Prevention Group 2 Surfaces Product Description Med Aire Low Air Loss, 5". 1/EA
Drive Devilbiss Healthcare
14025NS
In Commercial Distribution

  • 00822383007410 ()


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

DRIVEMEDICAL - 00822383262420

Pressure PreventionSales Samples Product Description: Gravity 7 Mini Mattress,1ea
Drive Devilbiss Healthcare
15770MINI
In Commercial Distribution

  • 00822383262420 ()


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

Drive - 00822383257471

10" Lateral Rotation Mattress with on Demand LAL
Drive Devilbiss Healthcare
LS9500
Not in Commercial Distribution

  • 00822383257471 ()


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

Drive - 00822383257464

LS9000 True Low Air Loss Mattress System
Drive Devilbiss Healthcare
LS9000
Not in Commercial Distribution

  • 00822383257464 ()


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

DRIVEMEDICAL - 00822383254609

Pressure PreventionSales Samples Product Description: Mattress MINI 14029 Sample,1/ea
Drive Devilbiss Healthcare
14029M-MINI
In Commercial Distribution

  • 00822383254609 ()


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

Drive - 00822383253374

Pressure PreventionSales Samples Product Description: 15019 Mattress Mini Sample,1/ea
Drive Devilbiss Healthcare
15019MINI
In Commercial Distribution

  • 00822383253374 ()


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

Drive - 00822383251936

Pressure PreventionSales Samples Product Description: Sample 14893 Mini Gel Overlay,1/ea
Drive Devilbiss Healthcare
14893MINI
In Commercial Distribution

  • 00822383251936 ()


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

Drive - 00822383227788

APP System, Standard, 220 Volt, 1/ea
Drive Devilbiss Healthcare
14002E-220
Not in Commercial Distribution

  • 10822383227785 ()
  • 00822383227788 ()


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

Drive - 00822383227771

APPSysDlxVariablPressure220V,50Hz,1eaRTL
Drive Devilbiss Healthcare
14001E-220
Not in Commercial Distribution

  • 10822383227778 ()
  • 00822383227771 ()


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

Med Aire - 00822383221618

Med Aire Low Air Loss, 8in
Drive Devilbiss Healthcare
14027
In Commercial Distribution

  • 00822383221618 ()


  • 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
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