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The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is indicated for use in the routine monitoring of temperature, as well as heart and respiratory sounds, in an anesthetized patient. The device is intended for insertion into the esophagus.

The subject device of this premarket 510(k) notification is referred to as the Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM.

The legacy Esophageal Stethoscope (K811862) was originally cleared on July 10, 1981, under the name "Hi-Lo Temp® Esophageal Stethoscope with a Thermistor Sensor." It has since been renamed to "Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM."

The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is currently the marketed device that is undergoing a material modification to eliminate DEHP and Phthalates.

The Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM monitors temperature and heart and breath sounds.

Features and benefits:

• Soft, thin cuff
• Male Luer fitting conveniently attaches to standard acoustical earpieces
• Long lead wire keeps connector away from the surgical field
• Compatible with most multifunction patient monitors

The Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 12 Fr 50/case CFN 90041, 18 Fr 50/case CFN 90042, 24 Fr 50/case CFN 90043, and 9 Fr 50/case CFN 90049. The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

A 400 series thermistor is placed in a PVC clear tube and sealed by a blue plastisol cuff. This end of the tube is inserted into the esophagus and directly contacts mucosa. In the opposite end of the tube, there is a luer connector and a thermistor connector. The luer connector should be attached to a standard earpiece and the thermistor connector should be inserted to an appropriate interface cable.

Each probe is electrically connected to a compatible interface cable which is specified in Table 1. The interface cable connects the probe to a patient monitor, which is compatible with the 400 series thermistor, so that the temperature measurement value is displayed on the screen of the monitor. All patient monitors that meet the specifications for the 400 series thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 3: Illustration of Patient Monitor Compatibility.

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