Good Morning Snore Solution
- Primary DI
- 00627843257127
- Brand
- Good Morning Snore Solution
- Company
- MPowRx Health and Wellness Products 2012 Inc
- Model
- 1
- Device description
- The Good Morning Snore Solution - An intraoral device for the reduction of snoring for adults at least 18 years old. Regular size.
- Published
- 2016-12-05
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Contact Domains#
goodmorningsnoresolution.comProduct Codes#
| Code | Name |
|---|---|
| LRK | Device, Anti-Snoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K193239 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00627843257127 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00627843257127 | 00627843257127 | 627843257127 | 0627843257127 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 | 0 |
Contacts#
| Phone | |
|---|---|
| 1-877-867-6979 | info@goodmorningsnoresolution.com |
Regulatory Flags#
- DUNS number
- 203417571
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00821514000054 | Good Morning Snore Solution | 2 | 2026-07-16 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850077473005 | EMA NOW PATIENT STARTER KITS | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473012 | EMA Serena Patient Starter kits | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473043 | INDIVIDUAL EMA STRAPS(EMAST13W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473050 | Individual EMA Straps(EMAST14W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473067 | Individual EMA Straps(EMAST15W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473074 | Individual EMA Straps(EMAST16W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473081 | Individual EMA Straps(EMAST17W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473098 | Individual EMA Straps(EMAST18W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473104 | Individual EMA Straps(EMAST19W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473111 | Individual EMA Straps(EMAST20W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473128 | Individual EMA Straps(EMAST21W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473135 | Individual EMA Straps(EMAST13Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473142 | Individual EMA Straps(EMAST14Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473159 | Individual EMA Straps(EMAST15Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473166 | Individual EMA Straps(EMAST16Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473173 | Individual EMA Straps(EMAST17Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473180 | Individual EMA Straps(EMAST18Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473197 | Individual EMA Straps(EMAST19Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473203 | Individual EMA Straps(EMAST20Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473210 | Individual EMA Straps(EMAST21Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473227 | Individual EMA Straps(EMAST13B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473234 | Individual EMA Straps(EMAST14B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473241 | Individual EMA Straps(EMAST15B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473258 | Individual EMA Straps(EMAST16B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473265 | Individual EMA Straps(EMAST17B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473272 | Individual EMA Straps(EMAST18B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473289 | Individual EMA Straps(EMAST19B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473296 | Individual EMA Straps(EMAST20B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473302 | Individual EMA Straps(EMAST21B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473319 | Individual EMA Straps(EMAST13C) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |