Device Description (max 2000 characters):The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standardendoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestinewhile utilizing the existing endoscope optics and utilities.The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through theinstrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloonair supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of theballoon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
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