ClearDream

GUDID 00860313000803

KELLER LABORATORIES, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00860313000803
• NIH Device Record Key: 5bc5c602-7358-4e64-b7da-38f7b34d1421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearDream
• Version Model Number: ClearDream
• Company DUNS: 801156050
• Company Name: KELLER LABORATORIES, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860313000803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133390

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-27