Ebb Insomnia Therapy 10401

GUDID 00864302000355

Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to allow the tubing to be wiped down for cleaning.

CEREVE INC

Circulating-fluid thermal therapy system

• Primary Device ID: 00864302000355
• NIH Device Record Key: c6d34a49-960c-48a2-8888-672fe80a79c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ebb Insomnia Therapy
• Version Model Number: EOS-30000-054
• Catalog Number: 10401
• 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	00864302000355 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-06-07
• Device Publish Date: 2018-05-07

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