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Genio System 2.1
The Genio Patient Kit contains one Activation Chip Model #2364 (Primary DI: 05404031024847) one Charging Unit Model #2238 with power adapters (Primary DI: 05404031024823), three boxes of Disposable Patches (Primary DI: 05404031018723), a Patient Manual (instructions for use) and a Quick Setup Guide. The Patient Kit is provided to the patient at the time of initial device activation.
Details
Device typeImplantable sleep apnoea treatment system, fixed-rate: An assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide fixed-rate electrical stimulation to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)]. It may take two forms: 1) an implanted pulse generator with implanted lead and electrode cuff with a portable patient-operated remote controller/charger; or 2) an unpowered stimulator with paddle electrodes with an external battery-powered control unit which supplies power telemetrically to the implant. It will include dedicated application software used by a healthcare professional for device configuration.
FDA categoryStimulator, Hypoglossal Nerve, Implanted, Apnea
Device ID05404031024786
Catalog numberNX-PKG-002478
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information