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 ID: 20857915006146
• NIH Device Record Key: 7f1d732c-f02f-4956-9f31-5c379b0465d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnsoETM
• Version Model Number: ECD06-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: true
• 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: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com
• Phone: +1 888-534-4873
• Email: info@attune-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915006142 [Primary]
GS1	10857915006149 [Package]; Contains: 00857915006142; Package: Shelf Box [4 Units]; In Commercial Distribution
GS1	20857915006146 [Package]; Contains: 10857915006149; Package: Shipper Box [1 Units]; In Commercial Distribution

FDA Product Code

• KMJ: Lubricant, Patient

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-09
• Device Publish Date: 2018-09-08

On-Brand Devices [EnsoETM]

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