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Haemotronic, S.P.A.

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Web: http://www.haemotronic.it
E-Mail:
Address: Via Carreri 16, PO Box 77, Mirandola 41037, Italy
Phone: +39-(535)-619611 | Fax: +39-(535)-24286 | Map/Directions >>
 
 

Profile: Haemotronic, S.P.A. is a provider of medical disposables and a large variety of products and services for the healthcare market. We develop, design and manufacture a wide assortment of medical devices for the medical and pharmaceutical industry. We also export our products to various countries worldwide. Our products include male luer connectors, dialyser connectors, three-way connectors, drip chambers, burettes, pressure pillows and suspended spikes. Our custom and OEM division serves manufacturers in the pharmaceutical and medical device industries.

FDA Registration Number: 9611157
US Agent: David Lennarz / Registrar Corp
Phone: +1-(757)-224-0177  Fax: +1-(757)-224-0179  E-Mail:

13 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.
• 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.
• Cardiopulmonary Bypass Pump Tube (FDA Code: DWE / 870.4390)
A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.
• Dialyzer Connector with Vented Caps
• Dialyzer Connectors
• Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ / 876.5630)
(1) A peritoneal dialysis 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 a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.
• Double Male Luer Connectors
• Female Luer Male Rekord Connectors
• 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:
• Intravenous Administration Kit (FDA Code: FPA / 880.5440)
• Patient Feeding Universal Connectors
• Rotating Male Luer Locks
• Self-Ejecting Rotating Male Luer Locks

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