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DyeVert™ NG Contrast Reduction System: The DyeVert™ NG Contrast Reduction System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL. DyeVert™ Plus Contrast Reduction System: The DyeVert™ Plus Contrast Reduction System consists of a Display and DyeVert Plus Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, lohexol 300 or 350 mg/mL and Iopamidol 370 mg/ mL. DyeTect™ Contrast Monitoring Disposable Kit: The DyeTect™ Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Contrast Monitoring Display during angiographic or CT procedures requiring controlled infusion of radiopague contrast media. Smart Syringe: The Smart Syringe is to be used with the DyeVert™ Plus Contrast Reduction System or the Contrast Monitoring System. The DyeVert™ Plus Contrast Reduction System is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/l mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mg/mL. The Contrast Monitoring System is to be used during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. DyeVert Plus EZ Disposable Kit: The DyeVert™ Plus EZ Contrast Reduction System consists of a Display and DyeVert Plus EZ Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mgI/mL.

The DyeVert NG, DyeVert PLUS and DyeVert PLUS EZ Systems are compatible to manual contrast injections and provide fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes also referred to as 'refluxed contrast') is minimized in the patient's vasculature. This allows for a reduction in total contrast agent volume during coronary or peripheral imaging: while maintaining adequate image quality. The DyeTect System is compatible to manual contrast injections and provides monitoring of the amount of contrast delivered to the patient. The Smart Syringe is also manufactured as a replacement that can be used with the DyeVert Plus, DyeTect or DyeVert Plus EZ systems.

The device consists of a display to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. The DyeVert™ Plus EZ Contrast Reduction System consists of a Display and DyeVert Plus EZ Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mgI/mL.

The Osprey Medical DyeVert™ Plus EZ Contrast Reduction System is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality. Age, diabetes, moderate and severe chronic kidney disease and heart failure on presentation are leading factors for when to consider renal protection measures such as contrast minimization tools and processes. The DyeVert Plus EZ Contrast Reduction System consists of the: 1. Contrast Monitoring Display (provided separately) and 2. DyeVert Plus EZ Disposable Kit. The DyeVert Plus EZ Disposable Kit consists of the Smart Syringe and DyeVert Plus EZ Module. The DyeVert Plus EZ Disposable Kit is intended to be used with the Contrast Monitoring Display to allow monitoring and display of contrast volumes manually injected. Volumes are displayed and compared to physician entered contrast usage thresholds during angiographic procedures. The DyeVert Plus EZ Module has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment"; and the catheter configurations listed below. Utilization of catheters beyond those listed has not been substantiated.

The Smart Syringe is to be used with the DyeVert™ Plus Contrast Reduction System or the Contrast Monitoring System. The DyeVert™ Plus Contrast Reduction System is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/l mL, Iohexol 300 or 350 mgl/mL and Iopamidol 370 mg/mL. The Contrast Monitoring System is to be used during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

The Smart Syringe is a component to the DyeVert™ Plus Contrast Reduction System and Contrast Monitoring System. The Smart Syringe is not intended to be used independently. The Smart Syringe is a control syringe with wireless communication capability to the Osprey Medical DyeVert Plus and Contrast Monitoring Display.

The DyeVert™ NG Contrast Reduction System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL. The DyeVert™ Plus Contrast Reduction System consists of a Display and DyeVert Plus Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mg/ mL.

The Osprey Medical DyeVert" NG and DyeVert" Plus Contrast Reduction Systems are compatible to manual contrast injections and provide fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes also referred to as "refluxed contrast') is minimized in the patient's vasculature. This allows for a reduction in the total contrast agent volume during coronary or peripheral imaging to the patient; while maintaining adequate image quality.

Display: The device consists of a display to be used with the DyeVert Plus Disposable Kit or the Contrast monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. DyeVert Plus Disposable Kit: The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display and DyeVert Plus Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mgI/mL. Contrast Monitoring Disposable Kit: The device consists of a Smart Syringe and Pressure Module to be used with the Contrast Monitoring Display during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

The Osprey Medical DyeVert™ Plus Contrast Modulation/Monitoring System is a compatible system to manual contrast injections and provides fluid pathway resistance modulation and/or monitoring such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes also referred to as 'refluxed contrast') is minimized in the patient's vasculature. This allows for a reduction in total contrast agent volume during coronary or peripheral imaging; while maintaining adequate image quality. The DyeVert Plus Contrast Modulation/Monitoring System consists of the Display and the DyeVert Plus Disposable Kit. The Contrast Monitoring System is a component of the DyeVert™ Plus Contrast Modulation/Monitoring System and also provided separately. The system allows for real-time, wireless, monitoring and display of manually injected contrast volumes. Volumes are displayed and compared to a physician entered contrast usage threshold during angiographic procedures. The system provides a visual and audible indication of when the cumulated volume injected into the patient is approaching a physician determined contrast volume threshold. This allows for attentive physician decision-making of total contrast volume use during a patient case while allowing the physician's primary focus to remain on the image and therapeutic need of imaging. When sold separately, the Contrast Monitoring System consists of the Display and the Contrast Monitoring Disposable Kit.

The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

The Osprey Medical DyeVert™ NG Contrast Modulation System (DyeVert System) is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality. The DyeVert System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir. The DyeVert System has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.

The DyeVert™ Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

The Osprey Medical DyeVert™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature, retrograde to the desired image area. The DyeVert™ System allows for the modulated reduction of contrast media during manual injections in coronary or peripheral imaging procedures. The DyeVert™ System is a device for physician utilization during efforts to minimize total patient contrast volumes. The DyeVert™ System consists of a sterile, single-use, fully-disposable apparatus. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.

The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgUml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml.

The Osprey Medical AVERT™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient during the manual injection of contrast media while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature retrograde to the desired image area. The AVERT™ System allows for the modulated reduction of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT™ System is a device for physician utilization during efforts to minimize total patient contrast volumes. The AVERT™ System consists of a reusable, non-sterile apparatus (contrast modulator), which applies a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.

The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: Iodixanol 320 mg/mL and Iopanidol 370 mg/l mL.

The Osprey Medical DyeVert™ Contrast Modulation System (DyeVert System) allows for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. The Dyevert System consists of a sterile, single-use, fully-disposable apparatus which provides a secondary fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.

The AVERT™ Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 300 or 370 mgI/mL.

The Osprey Medical AVERT™ Contrast Modulation System allows for the modulation of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT System consists of a reusable, non-sterile apparatus (contrast modulator), which a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.