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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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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

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

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

NxStage PureFlow Solution - M535RFP205WW0

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

  • M535RFP205WW5 ()
  • M535RFP205WW0 ()


  • Haemodialysis dialysate solution

ESTREMO - 08052990979745

No Description
CITIEFFE SRL
Fracture alignment guide wire exchange tool
In Commercial Distribution

  • 08052990979745 ()
EBA-5316

  • Orthopaedic bone-fragment manipulator, reusable

Orthopaedic Surgical Instruments - 08032909622009

No Description
CITIEFFE SRL
Fracture alignment guide wire exchange tool
In Commercial Distribution

  • 08032909622009 ()
DT010020

  • Orthopaedic bone-fragment manipulator, single-use, non-sterile

EBA2 - 08032909627813

No Description
CITIEFFE SRL
Fracture alignment guide wire exchange tool
In Commercial Distribution

  • 08032909627813 ()
EBA-5120

  • Orthopaedic bone-fragment manipulator, reusable

ESTREMO - 08059386742501

No Description
CITIEFFE SRL
Fracture alignment guide wire exchange tool
In Commercial Distribution

  • 08059386742501 ()
EBA-5306

  • Orthopaedic bone-fragment manipulator, reusable

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 - 00822383990101

Pressure PreventionBlank Product Description: Gravity 9 Mattress 39"W x 80"L x 6"H
Drive Devilbiss Healthcare
G9-39X80X6
In Commercial Distribution

  • 00822383990101 ()


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

DRIVEMEDICAL - 00822383990095

Pressure PreventionBlank Product Description: Gravity 7 Mattress 39"W x 80"L x 6"H
Drive Devilbiss Healthcare
G7-39X80X6
In Commercial Distribution

  • 00822383990095 ()


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

DRIVEMEDICAL - 00822383986999

Pressure PreventionSales Samples Product Description: Shearcare 1500 MattressMini Sampl, 1/EA
Drive Devilbiss Healthcare
1500SCMINI
In Commercial Distribution

  • 00822383986999 ()


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

DRIVEMEDICAL - 00822383972060

Pressure PreventionGroup 2 Surfaces Product Description: True LAL LS9000 P/L for Integra 48"
Drive Devilbiss Healthcare
IH-LS900048
Not in Commercial Distribution

  • 00822383972060 ()


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

DRIVEMEDICAL - 00822383932187

Pressure PreventionSales Samples Product Description: MATTRESS MINI 14530 SAMPLE
Drive Devilbiss Healthcare
14530M-MINI
In Commercial Distribution

  • 00822383932187 ()


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