AccessGUDID - DEVICE: Good Morning Snore Solution (00627843257127)

GUDID

Device Identifier (DI) Information

Brand Name: Good Morning Snore Solution
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MPowRx Health and Wellness Products 2012

Primary DI Number: 00627843257127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203417571 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRK	Device, Anti-Snoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193239	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2f10636-3f54-402b-8df8-34cbb59a5352
Public Version Date: January 21, 2020
Public Version Number: 5
DI Record Publish Date: December 05, 2016