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The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.

The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.

The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms.

The Maxtec MaxCap Neo and MaxCap Ped are indicated to provide a semi-quantitative visualization of the CO2 in the patient airvay. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg Environment of Use: Hospital, sub-acute, pre-hospital, transport.

The proposed MaxCap Neo and MaxCap Ped are comprised of several components: - . Housing with standard 15 mm / 22 mm fittings to connect to the ventilator assist device and a face mask or endotracheal tube - . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH

The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e.. hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.

The MaxBlend family of blenders, MaxBlend 2 and MaxBlend Lite, are oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly. The air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. The MaxBlend 2 incorporates the air/oxygen blender within its enclosure. The MaxBlend Lite may be provided with or without the blender component pre-assembled, allowing the user to install the oxygen monitor/flowmeter module, the MaxBlend Lite component, on an existing compatible blender. The addition of the MaxBlend Lite module is intended to improve the safety of an existing air/oxygen blender that is in the user's possession. Both devices use the exact same oxygen monitor sensor and electronics, MaxO2ME (K153659). Both devices use the exact same components/assemblies in the flowmeter and sensor bleed manifold which form the gas pathway to the patient. The only substantive difference is the form of the enclosure for the monitor electronics.

The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.

The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.

The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.

The UltraMaxO2 device is used for checking oxygen concentrator performance with the measure of oxygen purity, and flow at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer functions by passing an ultrasonic pulse through the gas sample and measuring the amount of time required for the pulse to transit the sample chamber. The transit time is converted into a gas concentration via calibration data stored in the device. This can be done because the transit time varies according to the molecular mass of the gas in the chamber. Flow is determined using the difference between the ultrasonic pulse traveling against the flow and the ultrasonic pulse traveling with the flow. Pressure is measured using a separate pressure sensor that measures the pressure build-up in the device when the output port is blocked. The pressure is displayed in either kPa or PSI determined by a user operable switch in the battery compartment. The materials of the UltraMaxO2 include ABS plastic for the enclosures and the ultrasonic oxygen sensor tube body, adhesive backed Polycarbonate labels, PVC tubing and nickel plated brass fittings for the flow path, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors and an LCD screen.