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The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainary bladder and simultaneous monitoring of core body temperature.

The Foley Catheter with Temperature Sensor is used for drainage of the urinary bladder and simultaneous monitoring of core body temperature. The device consists of a temperature-sensing wire set secured inside the lumen of a silicone Foley catheter. It is available in 14, 16, and 18 French size catheters. The French size and balloon volume are designated on the device itself. The wire set contains a thermistor chip, which is located near the distal tip of the catheter. The thermistor passively modifies the electrical current traveling through the wire set. A blue connector is located at the proximal end of the device. This connector interfaces with a cable that is connected to an independent temperature monitor used to display temperature readings. The catheters are individually packaged and sold sterile. The subject device is identical to the predicate device with the exception of the encapsulation method of the thermistor chip.

Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244): The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to temperature probes usage. The device is indicated for use by qualified medical personnel only.

Disposable Foley catheters with temperature probe are used for drainage of the urinary bladder and simultaneous patient temperature measurement. These Foley catheters with temperature probe consist of the "Molex" plug connector on the adapter cable end, urine output flow path with a balloon and a thermistor inside the catheter. These probes are to be used with 400-series compatible temperature measurement systems only. The temperature probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These catheters have a skin and core contact with a patient. Catheters are shipped in sterile condition and there is a shelf life declared for each manufacturing batch. These Foley catheters with temperature probe can be used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175). Products are packed inside a cardboard box having 25 pcs of individually packed products (inside a plastic/ paper pouch) in sterile condition. The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution "Rx Only (USA). U.S. Federal law restricts this device to sale by or on the order of a physician." There is one instruction for use insert in the sales package of 25 probes.

DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Temperature Sensors are to be used for drainage of the urinary bladder and monitoring of temperature.

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