SnoreByte Express 3530

GUDID B14035301

Kit including the Silent Sleep tray, intended as a temporary or trial device in the treatment of snoring or obstructive sleep apnea. Kit contains Silent Sleep Tray, bite wheel, carrying case.

Braebon Medical Corporation

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

• Primary Device ID: B14035301
• NIH Device Record Key: 5b7bbdd9-3f5a-4a50-b433-e058a527e8e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnoreByte Express
• Version Model Number: 3530
• Catalog Number: 3530
• Company DUNS: 251731105
• Company Name: Braebon Medical Corporation
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14035301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082849

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2023-06-19
• Device Publish Date: 2023-06-09

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