SmartGuard

GUDID 00866330000260

Mandibular Advancement Device to reduce snoring

Smartguard Rx, Inc.

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00866330000260
• NIH Device Record Key: cb3020b2-ab3e-4e1a-be33-03dfdd530037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartGuard
• Version Model Number: SGASD
• Company DUNS: 079556398
• Company Name: Smartguard Rx, 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com
• Phone: 8555762785
• Email: brian@smartguardrx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866330000260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200657

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: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [SmartGuard]

• 10866330000205: Dental mouth guard for clenching and grinding teeth (bruxism)
• 00866330000260: Mandibular Advancement Device to reduce snoring