ZQuiet

GUDID 00858522003173

ZQuiet 2-Pack Contains: (1) ZQuiet Comfort 1 Device, (1) ZQuiet Comfort 2 device, and (1) Storage Case.

SLEEPING WELL, LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00858522003173
• NIH Device Record Key: ae7c80f3-36f3-4001-b734-f386199b84cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZQuiet
• Version Model Number: ZQ2PK
• 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	00858522003173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093407

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]

• 00858522003197: ZQuiet Comfort 2 Refill Unit
• 00858522003180: ZQuiet Comfort 1 Device refill unit.
• 00858522003173: ZQuiet 2-Pack Contains: (1) ZQuiet Comfort 1 Device, (1) ZQuiet Comfort 2 device, and (1) Storag