Esophageal Cooling Device

GUDID 20857915006016

The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, and provide gastric decompression and suctioning.

Attune Medical

Thermal-regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube Core temperature regulation orogastric tube
Primary Device ID20857915006016
NIH Device Record Key5f49f53d-edee-4afb-9a9c-f24ff8efe310
Commercial Distribution Discontinuation2017-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEsophageal Cooling Device
Version Model NumberECD02-A
Company DUNS961627382
Company NameAttune Medical
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com
Phone888-534-4873
Emailinfo@advancedcoolingtherapy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857915006012 [Primary]
GS110857915006019 [Package]
Contains: 00857915006012
Package: Shelf Box [4 Units]
Discontinued: 2017-12-31
Not in Commercial Distribution
GS120857915006016 [Package]
Contains: 10857915006019
Package: Shipping Box [1 Units]
Discontinued: 2017-12-31
Not in Commercial Distribution

FDA Product Code

PLAEsophageal Thermal Regulation And Gastric Suctioning Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Esophageal Cooling Device]

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