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Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.

The Unimed Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed to function the same as the compatible Original Equipment Manufacturer (OEM) Pulse Oximeter Sensor. The sensors contain two specific wavelength LEDs and a photo detector assembled into the sensor housing. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. Four types of sensor housings are described in this submission: - Reusable soft tip sensor comprised of an integrated silicone rubber tip. - Reusable finger clip sensor with rigid halves and silicone pads - Disposable non- adhesive sensor with sponge and velcro backing. - Disposable adhesive sensors constructed of a medical tape laminate. Each sensor has unique labeling and specifications designed for compatibility with the specific monitor (Nellcor, Nonin, BCI, Ohmeda).

The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for used by qualified medical personnel only.

Unimed Skin Temperature Probe (T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS), and Unimed General Purpose Temperature Probe (T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG) are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with YSI 400 series compatible temperature measurement systems only. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.

The Unimed disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.

Unimed's Spo2 reusable sensors are designed to function the same as the compatible Original Equipment Manufacturer (OEM) Puise Oximeter Sensor. The sensors contain two specific wavelength LEDs and a photo detector assembled into the silicon pads. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.

The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Unimed's most common cable lead wire configuration ECG cables with specific various length are the replacements for similar cables manufactured by Original Equipment Manufacturers(OEM) and other third party after market manufacturers for their respective monitors. 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 Unimed cables use the same type of constructions 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 integral relief.