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The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity. This device should only be used by a physician or qualified personnel under the direction of a physician. Care must be taken to ensure compliance with the manufacturer's instructions for use. Prescription Use Only (Per 21 CFR 801.109)

The Gemini Standard and Mini Valves are contoured silicone elastomer valves substantially equivalent to legally marketed predicate devices used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valves incorporate an internal low, medium or high pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The devices also prevent retrograde flow. Integral occluders are incorporated on the proximal and distal ends of the valves. The occluders are designed to manually control the flushing or pumping of CSF proximally or distally. The devices are fitted with a polypropylene needle guard, designed to prevent needle puncture through the valve base during percutaneous injection. The devices contain an integral plastic connector on each end to simplify the attachment of the catheters during the clinical procedure. The devices do not contain any ferrous metal parts which would interfere with magnetic resonance imaging or computerized axial tomography.