Sparton Medical Systems

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Contact: Duane Stierhoff - Sr. Vice President
Web: http://www.spartonmedicalsystems.com
E-Mail:
Address: 22740 Lunn Rd., Strongsville, Ohio 44149, USA
Phone: +1-(440)-878-4630 | Map/Directions >>

Profile: Sparton Medical Systems deals with the design, development and manufacturing of medical devices. Some of our core competencies are precision fluidic handling systems, robotic handling systems, thermally controlled systems, lasers/optics and embedded systems.

The company is ISO 13485, CE certified.

FDA Registration Number: 3003144120

17 Products/Services (Click for related suppliers)

• Anesthesia Gas-Machine (FDA Code: BSZ / 868.5160)

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.

• Anesthetic Infusion Pump (FDA Code: FRN / 880.5725)

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Automated Blood Cell Diluting Apparatus (FDA Code: GKH / 864.5240)

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

• Automated Urinalysis System (FDA Code: KQO / 862.2900)

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

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

• Engineering/Design Service

• Enumeration Circulating Cancer Cell Immunomagnetic System (FDA Code: NQI / 866.6020)

An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.

• Extremity Topical Oxygen Chamber (FDA Code: KPJ / 878.5650)

A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.

• Hybridization And/Or Nucleic Acid Amplification Assay For Detection Of Hepatitis C Rna, Hepatitis C Virus (FDA Code: MZP)

• Immuno-Hematology Automated Cell Washing Centrifuge (FDA Code: KSN / 864.9285)

An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.

• Implantable Aneurysm Pressure Sensor (FDA Code: NQH / 870.2855)

• In Vitro Hiv Drug Resistance Genotype Assay (FDA Code: NHS / 866.3950)

• Medical Devices

• Negative Pressure Wound Therapy Powered Suction Pump (FDA Code: OMP / 878.4780)

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725)

• Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder (FDA Code: OBP / 882.5805)

A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

• Thermal Infusion Fluid Warmer (FDA Code: LGZ / 880.5725)