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U.S. Department of Health and Human Services

Product Classification

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Device esophageal thermal regulation and gastric suctioning device
Regulation Description Esophageal thermal regulation device.
Definition The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Physical State The device is a tube with three lumens made of standard medical-grade silicone. A connector allows the device to interface with an external controller, and another connector connects to wall suction.
Technical Method The device is inserted into the esophagus, and is attached to an external controller that provides heated or cooled water, which flows in a closed loop through two lumens. A third central lumen connects to wall suction for gastric decompression/suctioning.
Target Area The device is inserted into the esophagus and the tip reaches the stomach. The entire body is affected by the temperature of the fluid flowing through the device.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePLA
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.5910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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