ZQuiet S.A.

GUDID 00858522003241

ZQuiet S.A. Dental Size B Single Unit

SLEEPING WELL, LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00858522003241
• NIH Device Record Key: 52967bc5-dc71-4240-ad0f-d3457c9d51a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZQuiet S.A.
• Version Model Number: ZQSA-XDB
• Company DUNS: 020904101
• Company Name: SLEEPING WELL, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858522003241 [Primary]
GS1	10858522003248 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140777

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: 2016-09-24

On-Brand Devices [ZQuiet S.A.]

• 00858522003289: Contains 3 of each of the following packaged assemblies: ZQuiet S.A. Dental Size A Single Unit -
• 00858522003265: ZQuiet S.A. Dental Size D Single Unit
• 00858522003258: ZQuiet S.A. Dental Size C Single Unit
• 00858522003241: ZQuiet S.A. Dental Size B Single Unit
• 00858522003234: ZQuiet S.A. Dental Size A Single Unit
• 00858522003227: Oral Appliance System for Snoring and Obstructive Sleep Apnea Pack contains: (1) Size A mouthpie