SnoreMD

GUDID 00861481000305

Mouth Guard

APNEA SCIENCES CORPORATION

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00861481000305
• NIH Device Record Key: 4365e609-2d1a-4f65-a9f9-802fdd8f079d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnoreMD
• Version Model Number: 1
• Company DUNS: 070448734
• Company Name: APNEA SCIENCES 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861481000305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112205

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-15

Devices Manufactured by APNEA SCIENCES CORPORATION

• 00861481000305 - SnoreMD: 2018-07-06Mouth Guard
• 00861481000305 - SnoreMD: 2018-07-06 Mouth Guard
• 00861481000329 - ApneaRx: 2018-07-06 Small Mouth Guard
• 00861481000350 - SnoreRx: 2018-07-06 Mouth Guard
• 00861481000381 - ApneaRx: 2018-07-06 Standard Mouth Guard