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 Thermal-regulation orogastric tube Thermal-regulation orogastric tube Thermal-regulation orogastric tube Thermal-regulation orogastric tube Thermal-regulation orogastric tube Thermal-regulation orogastric tube Thermal-regulation orogastric tube 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 ID: 20857915006122
• NIH Device Record Key: 90a3e67a-6a27-4607-b3f3-b0b7ae240010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnsoETM
• Version Model Number: ECD05-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	00857915006128 [Primary]
GS1	10857915006125 [Package]; Contains: 00857915006128; Package: Shelf Box [4 Units]; In Commercial Distribution
GS1	20857915006122 [Package]; Contains: 10857915006125; Package: Shipping Box [1 Units]; In Commercial Distribution

FDA Product Code

• PIO: Enteral Specific Transition Connectors

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