Minntech Corporation

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Contact: Denise Bauer - Vice President
Web: http://www.minntech.com
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Address: 14605 28th Avenue N., Minneapolis, Minnesota 55447, USA
Phone: +1-(763)-553-3300, 800-328-3345 | Fax: +1-(763)-553-3387 | Map/Directions >>

Profile: Minntech Corporation develops, manufactures and markets medical devices, sterilants, & water purification products. We also develop core technologies in hollow fiber membrane devices, chemical sterilants, hemodialysis concentrates, and electronic products. Our products are used in kidney dialysis, open-heart surgery, endoscopy, and in the preparation of pure water for medical, industrial and laboratory use.

The company was founded in 1974, has revenues of USD 25-50 Million, has ~400 employees and is ISO 9001, CE certified.

FDA Registration Number: 2150060

29 Products/Services (Click for related suppliers)

• Air Bubble Detectors (FDA Code: FJF / 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.

• Air Bubble Monitor (FDA Code: FJF / 876.5820)

• Bicarbonate Hemodialysis Concentrates

• Cardiopulmonary Bypass Accessories (FDA Code: KRI / 870.4200)

Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.

• Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ / 870.4350)

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

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

• Dialyzer Reprocessing System (FDA Code: LIF / 876.5820)

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Endoscope Accessories (FDA Code: KOG)

• Endoscope Reprocessors

• Endoscopic Cleaning Accessories (FDA Code: FEB / 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.

• Extra-Luminal Blood Pump (FDA Code: FIR / 876.5820)

• Fistula Needle (FDA Code: FIE / 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.

• Hemobands

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

• Hemodialysis Concentrate Accessories, Acid Concentrate Adapter

• Hemodialysis Concentrate Accessories, Bicarbonate Concentrate Adapter

• Hemodialysis Concentrate Accessories, Drum Wrench

• Hemodialysis Concentrate Accessories, PVC Suction Hose

• 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 Filtrations

• Infection Prevention Solutions

• Inflation Bulb For Endoscope (FDA Code: FCY / 876.1500)

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

• Medical Device, Sterilant (FDA Code: MED / 880.6885)

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

• 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.

• Non-Remote Conductivity Meter (FDA Code: FIZ / 876.5820)

• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800)

A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

• Water Purification Subsystem (FDA Code: FIP / 876.5665)

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.