Ebb Insomnia Therapy

GUDID 00864302000324

Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomnia Therapy system.

CEREVE INC

Circulating-fluid thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system

• Primary Device ID: 00864302000324
• NIH Device Record Key: 34260796-f0c7-4894-86e2-e98c29b25ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ebb Insomnia Therapy
• Version Model Number: 10200
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864302000324 [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: 2018-01-22

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