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Bionic Medizintechnik GmbH

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Contact: Helmut Henrici - Regulatory Affairs Manager
Web: http://www.bionic-jms.com
E-Mail:
Address: Max Planck Str 21, Friedrichsdorf, Taunus 61381, Germany
Phone: +49-(6172)-7576-0 | Fax: +49-(6172)-7576-10 | Map/Directions >>
 
 

Profile: Bionic Medizintechnik GmbH specializes in the distribution of dialysis and transfusion products. We also manufacture catheters and therapy chairs & beds. We offer a wide range of medical single-use products. We supply blood bags and equipments needed for blood transfusion. Demers-Katheter® is a implantable atrial catheter for hemodialysis. With the Demers-Katheter®, it is possible to create permanent blood vessel access for dialysis in only a few minutes. It can be used for acute dialysis and for temporary or permanent access to the blood vessels of chronic dialysis patients. We offer a wide range of blood donation systems. Our blood bags features anti stick device and integrated blood sampling port. Our blood bags are available with CPDA-1 or CPD-SAGM solution that allows a storage of red cells up to 42 days. For the preparation of platelets from buffy coat or platelet rich plasma triple and quadruple blood bags have an integrated platelet storage bag with high oxygen permeability which allows a storage up to 5 days.

The company has revenues of USD 25-50 Million, has ~20 employees and is ISO 9001, CE certified.

28 Products/Services (Click for related suppliers)  
• A.V. Fistula Needle
• A.V.Fistula Needle Set
• Antimicrobial Central Venous Catheter
• Arterial Venous Fistula Needle
• Blood Transfusion Sets (FDA Code: BRZ / 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.
• Cannula Fistula Needle
• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210)
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
• Central Venous Catheter Insertion Simulator with Ultrasound
• Central Venous Catheter Kits
• Central Venous Catheters
• Disposable Vein Stripper (FDA Code: GAJ / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Dual Lumen Fistula Needle
• Femoral Catheter (FDA Code: LFK / 876.5540)
A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.
• Fistula Needle (FDA Code: FIE / 876.5540)
• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)
• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)
• Guarded Fistula Needles
• Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 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 Cannula
• Hemodialysis Fistula Needles
• Intravenous Administration Kit (FDA Code: FPA / 880.5440)
• Powered Dialysis Chair (FDA Code: FKS)
• Puncture Guard Fistula Needle
• Shelly Fistula Needle
• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200)
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
• Siliconized fistula needle
• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
• Stopcock, I.V.Set (FDA Code: FMG / 880.5440)

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