Ebb Insomnia Therapy

GUDID 00864302000300

Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps.

CEREVE INC

Circulating-fluid thermal therapy system

• Primary Device ID: 00864302000300
• NIH Device Record Key: da03dc24-af5a-4aa8-827c-bfc9adc54aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ebb Insomnia Therapy
• Version Model Number: EOS-30000-007
• Company DUNS: 877328174
• Company Name: CEREVE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com
• Phone: 800-381-1145
• Email: customersuccess@ebbsleep.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864302000300 [Primary]

FDA Product Code

• PLU: Thermal System For Insomnia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-30

On-Brand Devices [Ebb Insomnia Therapy]

• 00864302000355: Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to al
• 00864302000348: Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t
• 00864302000331: Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t
• 00864302000324: Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomni
• 00864302000300: Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t
• 00864302000317: Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and