Profile: Baxter International Inc. provides medicines for hemophilia, immune disorders, kidney disease and cancer. We manufacture plasma-based and recombinant proteins used to treat hemophilia. We offer biopharmaceutical products which include plasma-based therapies to treat immune disorders, alpha 1 antitrypsin deficiency and other chronic blood-related conditions. We deliver biosurgery products for hemostasis, wound-sealing and tissue regeneration. We produce intravenous (IV) solutions & administration sets, premixed drugs & drug reconstitution systems, pre-filled vials and syringes for injectable drugs. Our product suprane (desflurane, USP), a nonflammable liquid administered through vaporizer, is a general inhalation anesthetic. It is indicated as an inhalation agent for induction and/or maintenance of anesthesia for inpatient and outpatient surgery in adults. Our prefilled syringes for PCA pumps are individually packaged for easy storage and administration. It is color-coded for easy identification. It is packaged 10 per case & has tamper-evident syringe caps.

The company was founded in 1931. NYSE:BAX (SEC Filings)

FDA Registration Number: 2025695

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• Gastro-Urology Catheter & Accessories (FDA Code: KNY / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• General Diagnostic Equipment

• General Diagnostic Supplies

• General Diagnostics

• General Disinfectants

• General EMT

• General Hypodermic Supplies

• General Medical Supplies

• General OSHA Supplies

• General Surgery Supplies

• General Surgical Aids

• Gowns

• Guarded Fistula Needles

• Guide Catheters

• Hand Cleaners & Disinfectants

• Heart Catheters

• Heating Block (FDA Code: JRG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Hematocrit Measuring Device (FDA Code: JPI / 864.6400) A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

• Hematopoietic Stem Cell Separation System (FDA Code: MZK)

• Hemodialysis Access Recirculation Monitoring System (FDA Code: MQS / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 876.5820)

• Hemodialysis Blood Tubing Sets

• Hemodialysis Fistula Needles

• Hemodialysis systems

• Hemodialysis Unit Blood Pump

• Hemodialysis Units

• Heparin (FDA Code: IAZ / 864.4400) Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

• High Flux Re-Use Hemodialyzer (FDA Code: MSF / 876.5860) A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:

• High Permeability with/without Sealed Dialysate System (FDA Code: KDI / 876.5860)

• Hollow Fiber Capillary Dialyzer (FDA Code: FJI / 876.5820)

• Hospital Gowns

• Hot & Cold Therapy

• I.V. Catheter Extension Set

• I.V. Connector Loop

• I.V. Container (FDA Code: KPE / 880.5025) An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

• I.V. Filtration Sets

• I.V. Fluid Transfer Unit (FDA Code: LHI / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Implantable Cardiac Defibrillators

• Implantable Cardioverter Defibrillators

• Implantable Defibrillators

• Implanted Dialysis Bag

• Incentive Spirometers

• Infect Waste & Linen Disposal

• Infection Control Gowns

• Infusion Line Filter (FDA Code: FPB / 880.5440)

• Infusion Pump Analysis System

• Infusion Pump Repair

• Infusion Pump Service Parts

• Infusion Pump Stands