EnsoETM

GUDID 20857915006146

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, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.

Attune Medical

General-body orifice lubricant, non-sterile
Primary Device ID20857915006146
NIH Device Record Key7f1d732c-f02f-4956-9f31-5c379b0465d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnsoETM
Version Model NumberECD06-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
GS100857915006142 [Primary]
GS110857915006149 [Package]
Contains: 00857915006142
Package: Shelf Box [4 Units]
In Commercial Distribution
GS120857915006146 [Package]
Contains: 10857915006149
Package: Shipper Box [1 Units]
In Commercial Distribution

FDA Product Code

KMJLubricant, Patient

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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