Home GUDID 20857915006009 Esophageal Cooling Device
Primary DI 20857915006009
Brand Esophageal Cooling Device
Company Attune Medical
Model ECD01-A
Device 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.
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PLA Esophageal Thermal Regulation And Gastric Suctioning Device Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10857915006002 Package GS1 4 Not in Commercial Distribution 20857915006009 Package GS1 1 Not in Commercial Distribution 00857915006005 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10857915006002 10857915006002 20857915006009 20857915006009 00857915006005 00857915006005 857915006005 0857915006005
GMDN Terms# Term, Definition table Term Definition Thermal-regulation orogastric tube A non-sterile, multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) thermal regulation of the whole body via thermal transfer across the oesophagus (to lower and alternatively elevate core body temperature). It is typically a coaxial tube which includes an orogastric lumen, intended to allow access to the stomach for feeding/decompression/medication administration, and a closed circulating-fluid circuit intended to be connected to an appropriate thermal therapy system pump. This is a single-use device.
Regulatory Flags# DUNS number 961627382 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850041319001 EsoCool Nuvaira, Inc. PLA 2025-01-29 00850041319018 EsoCool Nuvaira, Inc. PLA 2025-01-29 00857915006128 EnsoETM Advanced Cooling Therapy, LLC PLA 2018-09-08 00857915006142 EnsoETM Advanced Cooling Therapy, LLC PLA 2018-09-08 00857915006166 EnsoETM Advanced Cooling Therapy, LLC PLA 2018-05-17 00857915006180 EnsoETM Advanced Cooling Therapy, LLC PLA 2018-05-17 00857915006203 EnsoETM Advanced Cooling Therapy, LLC PLA 2018-05-17 00857915006227 EnsoETM Advanced Cooling Therapy, LLC PLA 2018-05-17 20857915006160 EnsoETM Attune Medical PLA 2018-05-17 00857915006043 EnsoETM Advanced Cooling Therapy, LLC PLA 2017-07-24 00857915006050 EnsoETM Advanced Cooling Therapy, LLC PLA 2017-07-24 20857915006047 EnsoETM Attune Medical PLA 2017-07-24 20857915006054 EnsoETM Attune Medical PLA 2017-07-24 00857915006005 Esophageal Cooling Device Advanced Cooling Therapy, LLC PLA 2016-09-24 00857915006012 Esophageal Cooling Device Advanced Cooling Therapy, LLC PLA 2016-09-24 20857915006016 Esophageal Cooling Device Attune Medical PLA 2016-09-24
advancedcoolingtherapy.com
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