EnsoETM

GUDID 20857915006054

The EnsoETM 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
Primary Device ID20857915006054
NIH Device Record Keyecb6f8ec-6af5-4836-be0b-28241275c068
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnsoETM
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

Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com
Phone+1 888-534-4873
Emailinfo@attune-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857915006050 [Primary]
GS110857915006057 [Package]
Contains: 00857915006050
Package: Shelf Box [4 Units]
In Commercial Distribution
GS120857915006054 [Package]
Contains: 10857915006057
Package: Shipping Box [1 Units]
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 Date2017-07-24

On-Brand Devices [EnsoETM]

20857915006221The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanket
20857915006207The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Condu
20857915006184The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanket
20857915006160The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Condu
20857915006146The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-
20857915006122The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-
20857915006054The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanket
20857915006047The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Condu

Trademark Results [EnsoETM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENSOETM
ENSOETM
87382831 5429773 Live/Registered
ADVANCED COOLING THERAPY, INC.
2017-03-23

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