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The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.

AlV's Smart Label for Propofol is a replacement for the Smart Label manufactured by the Original Equipment Manufacturers (OEM) for the InfusO.R. pump. AIV does not manufacture the pump. The Smart Label for Propofol is an accessory for the pump and is also available as a replacement part. The AIV Smart Label for Propofol uses the same type of construction and has the same technological characteristics as the predicate device - the accessory supplied with the InfusO.R. pump. This device is not a kit and does not contain any electronic components. Construction of this device is substantially equivalent to the predicate device. AIV Smart Label for Propofol is not intended to make contact with the patient. The AIV Smart Label for Propofol is limited by the indications for use of the InfusO.R. pump.