ApneaRx

GUDID 00861481000381

Standard Mouth Guard

APNEA SCIENCES CORPORATION

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00861481000381
• NIH Device Record Key: ce78adf2-9aba-497a-a98f-749d5d367c59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApneaRx
• Version Model Number: Standard
• 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	00861481000381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113569

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

On-Brand Devices [ApneaRx ]

• 00861481000381: Standard Mouth Guard
• 00861481000329: Small Mouth Guard