Esophageal Cooling Device

GUDID 20857915006009

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.

Attune Medical

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• Primary Device ID: 20857915006009
• NIH Device Record Key: bcdc0c1c-0e55-467f-863d-1d55967a47cc
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Esophageal Cooling Device
• Version Model Number: ECD01-A
• Company DUNS: 961627382
• Company Name: Attune Medical
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com
• Phone: 888-534-4873
• Email: info@advancedcoolingtherapy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915006005 [Primary]
GS1	10857915006002 [Package]; Contains: 00857915006005; Package: Shelf Box [4 Units]; Discontinued: 2017-12-31; Not in Commercial Distribution
GS1	20857915006009 [Package]; Contains: 10857915006002; Package: Shipping Box [1 Units]; Discontinued: 2017-12-31; Not in Commercial Distribution

FDA Product Code

• PLA: Esophageal Thermal Regulation And Gastric Suctioning Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Esophageal Cooling Device]

• 20857915006016: The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Cincinnat
• 20857915006009: The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Gaymar Me