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The Retrograde Intubation Set is intended to assist in intubation during difficult or emergency airway access procedures in adult and pediatric patients. The 6 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 2.5 mm or larger. The 11 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 4 mm or larger. The 14 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 5 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 12 years of age.

The basic components included in the subject device, the Retrograde Intubation Set, are an introducer needle, catheter needle, syringe, hemostat, wire guide with wire guide inserter, intubation catheter, and Rapi-Fit® adapter. While the wire guide, intubation catheter, and Rapi-Fit® adapters are the subject of this De Novo request, this device is intended to be used with legally marketed needles, syringes, and hemostats. The needle and syringe are used to puncture the patient cricothyroid membrane and confirm needle placement in the patient airway. Then, a wire guide is inserted via the needle into a patient's trachea and exits via mouth or nose (i.e., retrograde). An intubating catheter is inserted orally or nasally over the wire guide into the trachea prior to intubation. This device offers optional Rapi-Fit adapters (attached to the intubating catheter) to facilitate supplemental oxygen delivery in adults prior to intubation with an endotracheal tube (ETT).