Profile: California MedTech develops and manufactures medical devices and life science instrumentation. Our product line includes intravascular cooling system, laser-based stroke treatment system, handheld digital keratometer, extracorporeal liver assist device, bone stenting system, nanofluidics processor, patient medication tracking system using RFID and bone growth stimulator . Our intravascular cooling system is a vapor compression-based hypothermia treatment system using a metallized heat-exchange catheter. Our bone stenting system is for reversibly reducing and stabilizing fractures of the long bones using a removable, resorbable stent device. Our handheld digital keratometer takes a digital image of eye and automatically measures diameter of pupil and iris, as well as curvature of cornea. Our laboratory and biotech instruments includes blood analyzers, immunoassay instruments, automated reagent processing systems, DNA analyzers, stem cell processing instruments, centrifuges and microfluidics processors.
The company is ISO-9001 , ISO-13485 certified.
FDA Registration Number: 2032077
14 Products/Services (Click for related suppliers)
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| • 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. |
| • Bone Growth Stimulators |
| • Bone Stenting Systems |
| • Cooling Intravenous Hypothermia System (FDA Code: NCX / 870.5900) A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. |
| • Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 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. |
| • ENT Nerve Stimulator (FDA Code: ETN / 874.1820) A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability. |
| • Extracorporeal Liver Assist Devices |
| • Handheld Digital Keratometers |
| • Interventional Catheter Systems |
| • Intravascular Cooling Systems |
| • Lipoplasty Suction System (FDA Code: MUU / 878.5040) A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap. |
| • Micro Pipette (FDA Code: JRC / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use. |
| • Muscle Rehabilitation Systems |
| • Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) |