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This device is an accessory for a syringe or infusion pump (not manufactured by AIV, Inc.). The healthcare worker connects the device to the corresponding pump. The patient uses the switch on the cable to signal the pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker. Connects to designated syringe or infusion pump model used in hospital, ambulatory and home care environments.

AIV's Patient Pendant Bolus Cables are a replacement for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective syringe and infusion pumps. AIV does not manufacture the pumps. These Patient Pendant Bolus Cables are an accessory for the pump and are also available as a replacement part. These cables include a switch and are plugged into a mating connector on the syringe or infusion pump to allow the patient to request medication within the parameters entered into the syringe pump by the healthcare provider and the designed limits on the pumps. The AIV Patient Pendant Bolus Cables use the same type of construction and have the same technological characteristics as the predicate device – the accessory supplied with the original pump. These are passive devices that contain no electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device. AIV Patient Pendant Bolus Cables use Biocompatible PVC for the cables, cable jackets and over molded connectors with an integral strain relief.

These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. AIV cables are limited by the Indications for Use of the connected recording/monitoring device.

AlV's Electrocardioaraph (ECG) cables (also sometimes referred to as trunk or leadwires) are replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient leadwires connect the trunk cable to the skin mounted ECG electrodes. These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor. The Trunk Cables have limited skin contact with the patient, while the Leadwires attached on the patient's chest have more continuous skin contact. The AIV cables use the same type of construction and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with an integral strain relief.

The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.

AIV's Clinical Electronic Thermometers (also referred to as Temperature Probes) are replacement thermometers for temperature monitoring/measuring systems. The device is reusable. The devices are electronic thermometers using a thermistor temperature sensor. The devices are placed inside a protective sheath (not manufactured or supplied by AIV). Then the thermometer is used on the patient by trained medical personnel. The sensor is displayed on a monitor/measuring system (not manufactured or supplied by AIV). The probe consists of a thermistor located in a metal tipped plastic shaft is attached to a plastic body that allows the protective sheath (not supplied component that actually touches the patient) to be gripped and ejected off the probe. A shielded multi-conductor cable is used to conduct thermistor signals to the connector for the monitor/measuring system. Some a heating resistor that allows a more rapid temperature measurement.

These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

AIV's Pulse Oximeter Adapter Cables are direct replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective monitors. They use the same type of construction and have the same technological characteristics as the predicate devices (OEM). The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient. AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate. AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions. AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors. The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors. The US transducers are used to detect the fetal heart rate using Doppier shift technology. These transducers are intended to be a direct replacement for the Corometrics transducers.

These devices are intended to be used as replacement door assemblies for Baxter Flo-Gard 6201 and Baxter Flo-Gard® 6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.

AIV's pump door assemblies are replacements for similar doors manufactured by Baxter Healthcare Corporation for their Flo-Gard® 6201 and Flo-Gard® 6301 Volumetric Infusion Pumps. The door is part of a linear peristaltic pumping mechanism. The door assemblies are intended to be direct replacement for the predicate device door assembly.