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Esophageal Cooling Device

Advanced Cooling Therapy, LLC · Model ECD01-A · UDI-DI 00857915006005

PLA Prescription
9
510(k) clearances
16
Adverse events (1 deaths)
0
Recalls
2
Facilities

Description

The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and provide gastric decompression and suctioning.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.