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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EXACTAMIX Compounder, Main Module Refurbished Unit
BAXTER HEALTHCARE CORPORATION
H9382400-MR
In Commercial Distribution

  • 00085412482644 ()
H9382400-MR

  • Intravenous solution compounder
EXACTAMIX Compounder, Main Module
BAXTER HEALTHCARE CORPORATION
H9382400-M
In Commercial Distribution

  • 00085412482637 ()
H9382400-M

  • Intravenous solution compounder
Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.9
In Commercial Distribution

  • 20085412676610 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software
Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System.
BAXTER INTERNATIONAL INC.
5C9400
In Commercial Distribution

  • 35413765565695 ()
5C9400

  • Nephrology information system application software
Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System.
BAXTER INTERNATIONAL INC.
5C9400
In Commercial Distribution

  • 45413765565692 ()
5C9400

  • Nephrology information system application software
UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Vantive Y-Set. The clamp is specifically designed to assist individuals who experience difficulty in operating other ancillary clamps or pre-attached clamps.
BAXTER HEALTHCARE CORPORATION
5C4957
In Commercial Distribution

  • 57332414208238 ()
  • 07332414208233 ()
  • 00085412070643 ()
5C4957

  • Medical tubing clip/clamp, temporary, non-calibrated, reusable
The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets.
BAXTER HEALTHCARE CORPORATION
5C4145NS
In Commercial Distribution

  • 57332414207934 ()
  • 07332414207939 ()
  • 70085412722893 ()
  • 00085412722894 ()

  • Total Volume: 15 Liter
5C4145NS

  • Peritoneal dialysis system tubing set
The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.
BAXTER HEALTHCARE CORPORATION
955516
In Commercial Distribution

  • 37332414123933 ()
  • 07332414123932 ()
955516

  • Conduction blood/fluid warmer set
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
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
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