Nautilus™* Smart ECMO Module is manufactured by MC3, Inc., and exclusively distributed by Medtronic.
Crescent™* jugular dual lumen is manufactured by MC3, Inc. and exclusively distributed by Medtronic.
Crescent™* RA jugular dual lumen catheter is manufactured by MC3, Inc. and exclusively distributed by Medtronic.
1 Design verification and validation data on file at MC3. These tests may not be indicative of clinical performance.
Nautilus™* Smart ECMO Module Important Safety Information
Only clinicians thoroughly trained in extracorporeal life support procedures should use this device. Read all warnings, precautions, and Instructions for Use carefully prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Crescent™* and Crescent™* RA Jugular Dual Lumen Catheters Important Safety Information
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.
Only physicians with previous training and experience with venous catheterization and extracorporeal life support should use this device.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Crescent™* and Crescent™* RA jugular dual lumen catheters are not approved in every geography.
Bio-Medicus Life Support™ Important Safety Information
- Only physicians trained and experienced in using percutaneous catheterization techniques (such as the Seldinger technique), ECMO, and ECLS should use this device.
- Note: The benefits of catheterization for extracorporeal circulation must be weighed against the risk of systemic anticoagulation and subsequent propensity for hemorrhage.
- Caution: Ensure that the catheter size selected is of adequate size for the vessel to allow distal perfusion of the limb when the catheter is in place. Improper catheter size may be difficult to advance. The vessel must be large enough to ensure perfusion and venous return.
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.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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