FDA product code PLA

Esophageal Thermal Regulation And Gastric Suctioning Device

Cardiovascular·Class 2·21 CFR 870.5910
US regulatory classifications
US Product Code (FDA)
PLA
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.5910
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

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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About this record

Esophageal Thermal Regulation And Gastric Suctioning Device is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.