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The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure.

The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a "back-up" ventilation system in the event of mechanical ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.

The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator is a disposable, single patient use, medical device which temporarily augments ventilation in patients during ventilatory insufficiency or ventilatory failure. As is the case with the device in the original submission, this modified resuscitator may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport. The only difference between the original device and this modified version is the presence of a pressure monitoring port located on the non-rebreathing valve component of the finished device assembly.

This document does not contain an AI/ML device. It describes a manual resuscitator. Therefore, the requested information about acceptance criteria for an AI/ML device and the study proving it meets those criteria cannot be extracted.

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