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The SMART BAG" Mo is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG®MD is available in a child and an adult size. The SMART BAG®MO is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG®MO includes a flow limiting valve that limits the inspiratory flow to approximately 40 litres per minute, for the adult version and 30 litres per minute for the child version. The flow limiting valve is intended to minimize gastric inflation during manual ventilation. The flow limiting valve can be disabled to permit conventional operation of the resuscitator".

The SMART BAG® MO is a manual resuscitator comprising a self inflating bag, a one way valve and a facemask designed to supply ventilations to a non-breathing patient by the compression of the bag portion of the device by the operator. Similar in all respects to the predicate device, 510(k) #: K973419, this product has the addition of a flow-limiting valve that is responsive to the squeeze of the balloon applied by the rescuer. In cases where high flowrates are required to overcome mask leakage or adverse patient conditions, the Manual Override Control is provided to disable the flow controlling mechanism and allow the SMART BAG ®MO to act like a standard BVM.