Good Morning Snore Solution

Basic Information

• Brand Name: Good Morning Snore Solution
• Primary DI: 00627843257127
• Version / Model: 1
• Company Name: MPowRx Health and Wellness Products 2012
• Labeler DUNS: 203417571
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-05
• Public Version: 5
• Public Version Date: 2020-01-21
• Public Version Status: Update
• Public Device Record Key: d2f10636-3f54-402b-8df8-34cbb59a5352

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47529	Tongue-retaining sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by retention of the tongue, frequently keeping the tongue in a forward position during sleep. It typically works by applying a gentle negative pressure that holds the tongue in a position that facilitates breathing, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627843257127	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K193239	000