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Esophageal Thermal Regulation And Gastric Suctioning Device

FDA product code PLA · 8 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.5910
Review panel
CV
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-01-15 – 2025-10-30

The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.

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