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<h2>Indications, Safety, and Warnings</h2> <h3>Indications For Use</h3> <p>The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.</p> <h3>Contraindication</h3> <p>This device is not designed, sold, or intended for use except as indicated.<br /> </p> <h3>Warnings and Precautions</h3> <p><b>Warning: Do not use without adequate systemic anticoagulation.</b></p> <p><b>Warning:</b> Use of the Jugular Dual Lumen Catheter beyond the duration established by the available in vitro and in vivo testing has not been demonstrated. Please refer to the Instructions for Use (sect. 9 & 14) for a summary of bench and animal studies performed and for the possible clinical observations that may necessitate or predict the need for device replacement/change-out throughout the duration of use for this device.</p> <p><b>Important Safety Information:</b> Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgery procedures. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.</p> <p>Only physicians with previous training and experience with venous catheterization and extracorporeal life support should use this device.</p> <p><b>Caution:</b> Federal law (USA) restricts this device to sale by or on the order of a physician.</p> <p>Crescent™* and Crescent™* RA jugular dual lumen catheters are not approved in every geography.</p> <p>UC202408577 EN</p>

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