Rest Assured
- Primary DI
- 20651080000004
- Brand
- Rest Assured
- Company
- RANIR, LLC
- Model
- 1C4
- Device description
- SNORE NO MORE 1CT
- Published
- 2020-04-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LRK | Device, Anti-Snoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10651080000007 | Package | GS1 | 3 | In Commercial Distribution |
| 20651080000004 | Package | GS1 | 4 | In Commercial Distribution |
| 00651080000000 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10651080000007 | 10651080000007 | ||
| 20651080000004 | 20651080000004 | ||
| 00651080000000 | 00651080000000 | 651080000000 | 0651080000000 |
GMDN Terms#
| Term | Definition |
|---|---|
| Mandible-repositioning sleep-disordered breathing orthosis | A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 364567615
- 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
- false
- 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 |
|---|---|---|---|---|
| 00651080651523 | Plackers | 78501 | 2024-04-26 | |
| 00651080651516 | Plackers-Grind No More | 78500 82744 | 2022-08-26 | |
| 10651080651520 | Plackers | 78501 | 2024-04-26 | |
| 00071031189521 | Rest Assured | ZWN | 2021-10-15 | |
| 10071031189528 | Rest Assured | ZWN | 2021-10-15 | |
| 00651080125512 | Plackers | UWB | 2020-05-20 | |
| 00651080000000 | Rest Assured | 1C4 | 2020-04-15 |
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 |