EnsoETM

GUDID 20857915006122

The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly.

Attune Medical

Thermal-regulation orogastric tube
Primary Device ID20857915006122
NIH Device Record Key90a3e67a-6a27-4607-b3f3-b0b7ae240010
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnsoETM
Version Model NumberECD05-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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100857915006128 [Primary]
GS110857915006125 [Package]
Contains: 00857915006128
Package: Shelf Box [4 Units]
In Commercial Distribution
GS120857915006122 [Package]
Contains: 10857915006125
Package: Shipping Box [1 Units]
In Commercial Distribution

FDA Product Code

PIOEnteral Specific Transition Connectors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-09
Device Publish Date2018-09-08

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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