Good Morning Snore Solution

GUDID 00627843257127

The Good Morning Snore Solution - An intraoral device for the reduction of snoring for adults at least 18 years old.

MPowRx Health and Wellness Products 2012

Tongue-retaining sleep-disordered breathing orthosis

• Primary Device ID: 00627843257127
• NIH Device Record Key: d2f10636-3f54-402b-8df8-34cbb59a5352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Good Morning Snore Solution
• Version Model Number: 1
• Company DUNS: 203417571
• Company Name: MPowRx Health and Wellness Products 2012
• 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: false
• Manufacturing Date: false
• 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: 1-877-867-6979
• Email: info@goodmorningsnoresolution.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627843257127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193239

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: 5
• Public Version Date: 2020-01-21
• Device Publish Date: 2016-12-05