B. Braun Avitum Italy S.P.A.

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Contact: Rebecca Stolarick
Web: http://www.bbraun.it
E-Mail:
Address: Via Xxv Luglio 11, Mirandola, Mirandola Mo41037, Italy
Phone: +39-(0535)-616711 | Fax: +39-(0535)-27593, 610809 | Map/Directions >>

Profile: B.Braun Avitum Italy S.P.A. provides patient lens care and services according to criteria of adequacy. We support the doctors, specialists, nurses and pharmacists. We contributed to the renewal of working procedures, treatment hospital, medical care, increasing patient safety, doctors and nurses. Our product new prosthetic knee AS is for patients allergic to nickel, chromium and cobalt. We also help spread highly specialized knowledge, both in products and technologies, in consulting services for streamlining hospital processes, such as updating of value added services for the client and the employee

FDA Registration Number: 9681240
US Agent: Rebecca A. Stolarick / B. Braun Medical, Inc.
Phone: +1-(610)-596-2536 Fax: +1-(610)-266-4962 E-Mail:

10 Products/Services (Click for related suppliers)

• Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 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.

• Central Multiple Patient Dialysate Delivery System (FDA Code: FKQ / 876.5820)

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

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

• 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. 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.

• Liquid Hemodialysis Dialysate Concentrate Solution (FDA Code: KPO / 876.5820)

• Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890)

A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

• Removal of Low Density Lipoprotein (FDA Code: MMY)

• Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN)