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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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Tecomet - 00841435111073

Bending Pliers
TECOMET INC.
PR50014
In Commercial Distribution

  • 00841435111073 ()


  • Surgical vice grip

Tecomet - 00841435111066

Bending Pliers
TECOMET INC.
47925
In Commercial Distribution

  • 00841435111066 ()


  • Surgical vice grip

Tecomet - 00841435119970

Locking Pliers
TECOMET INC.
2421-33-000
In Commercial Distribution

  • 00841435119970 ()


  • Surgical vice grip

PRISMASATE - 00085412645827

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 HEALTHCARE CORPORATION
106957
In Commercial Distribution

  • 50085412645822 ()
  • 00085412645827 ()
106957C

  • 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

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 - 07332414108618

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.
113918
In Commercial Distribution

  • 37332414108619 ()
  • 07332414108618 ()
113918

  • 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 - 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

RTCH T STEALTH 11 MM - 00810019932854

No Description
Bradshaw Medical, Inc.
AR-8964-23
In Commercial Distribution

  • 00810019932854 ()


  • Surgical vice grip

Bradshaw Medical Inc. - 00810019930584

R-GRP, LUMBAR SLIMLINE
Bradshaw Medical, Inc.
RG-000610DG-ATEC
In Commercial Distribution

  • 00810019930584 ()
RG-000601DG-ATEC

  • Surgical vice grip

Bradshaw Medical Inc. - 00810019930522

R-GRP, CERV SLIMLINE DG COLOR CODE
Bradshaw Medical, Inc.
RG-000505DG-ATEC
In Commercial Distribution

  • 00810019930522 ()
RG-000505DG-ATEC

  • Surgical vice grip

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 - 00822383561769

Pressure PreventionBlank Product Description: Gravity 9 Mattress 80" Custom 1/ea
Drive Devilbiss Healthcare
GRAVITY-9-CUSTOM
In Commercial Distribution

  • 00822383561769 ()


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

DRIVEMEDICAL - 00822383561745

Pressure PreventionBlank Product Description: Gravity 7 Mattress 80" Custom 1/ea
Drive Devilbiss Healthcare
GRAVITY-7-CUSTOM
In Commercial Distribution

  • 00822383561745 ()


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

DRIVEMEDICAL - 00822383549163

Pressure PreventionSales Samples Product Description: BA9600-NP MINI, 1/EA
Drive Devilbiss Healthcare
BA9600-NPMINI
Not in Commercial Distribution

  • 00822383549163 ()


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

Drive - 00822383521268

84" Non-PwrdSelfAdjAir/Foam Matt, 1/ea
Drive Devilbiss Healthcare
BA9600-NP-84
In Commercial Distribution

  • 00822383521268 ()


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

DRIVEMEDICAL - 00822383521251

Pressure PreventionGroup 2 Surfaces Product Description: 84" PwrdSelfAdjAir/Foam Matt, 1/ea
Drive Devilbiss Healthcare
BA9600-P-84
In Commercial Distribution

  • 00822383521251 ()


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

DRIVEMEDICAL - 00822383521084

Pressure Prevention Product Description: 36" Powered Self Adj.Air/Foam,Matt, 1/ea
Drive Devilbiss Healthcare
BA9600-PKG
Not in Commercial Distribution

  • 00822383521084 ()


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

DRIVEMEDICAL - 00822383521077

Pressure Prevention Product Description: 42" Powered Self Adj.Air/Foam,Matt,1/ea
Drive Devilbiss Healthcare
BA9600-P-42-PKG
Not in Commercial Distribution

  • 00822383521077 ()


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

DRIVEMEDICAL - 00822383520087

Pressure PreventionBlank Product Description: 6500DynamicElite Mattress,1/ea
Drive Devilbiss Healthcare
6500-DE-CUSTOM
In Commercial Distribution

  • 00822383520087 ()


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

DRIVEMEDICAL - 00822383517032

Pressure PreventionGroup 2 Surfaces Product Description: 42" Powered Self Adj.Air/Foam,Matt, 1/ea
Drive Devilbiss Healthcare
BA9600-P-42
In Commercial Distribution

  • 00822383517032 ()


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

Drive - 00822383517001

42" NonPoweredSelfAdj.Air/FoamMatt, 1/
Drive Devilbiss Healthcare
BA9600-NP-42
In Commercial Distribution

  • 00822383517001 ()


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

DRIVEMEDICAL - 00822383516998

Pressure PreventionGroup 2 Surfaces Product Description: Non-Powered Self Adj.Air/Foam Matt, 1/c
Drive Devilbiss Healthcare
BA9600-NP
In Commercial Distribution

  • 00822383516998 ()


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

Drive - 00822383512969

Pump Only, AS5000 & AS5300, 1/ea
Drive Devilbiss Healthcare
AS5120
In Commercial Distribution

  • 10822383512966 ()
  • 00822383512969 ()


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

Drive - 00822383511252

LS9000B 10" Low Air Loss and APM
Drive Devilbiss Healthcare
LS9000B42
Not in Commercial Distribution

  • 00822383511252 ()


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

Drive - 00822383505114

Pressure PreventionSales Samples Product Description: Gravity 8 mini mattress, 1/ea
Drive Devilbiss Healthcare
15870MINI
In Commercial Distribution

  • 00822383505114 ()


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

DRIVEMEDICAL - 00822383505091

Pressure PreventionSales Samples Product Description: Gravity 7 RR mini mattress, 1/ea
Drive Devilbiss Healthcare
15777MINI
In Commercial Distribution

  • 00822383505091 ()


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

DRIVEMEDICAL - 00822383291666

Pressure PreventionLTC and Hospice Product Description: Fall Mat 72 x 30 x 2in ,1/ea
Drive Devilbiss Healthcare
14700
In Commercial Distribution

  • 00822383291666 ()


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