O2Vent Mono (OVENT)
- Primary DI
- 09351567000004
- Brand
- O2Vent Mono (OVENT)
- Company
- OVENTUS MANUFACTURING PTY LTD
- Model
- O2Vent Mono
- Device description
- The OVENT device is for the treatment of snoringand/or obstructive sleep apnea and is comprised of:• A titanium bimaxillary oral appliance whichcomprises, in one device, a lower tray fitted over thelower teeth and an upper tray fitted over the upperteeth.• A dental polymer material in each tray which is incontact with and retaining in position, the user’s topand bottom teeth.• The lower jaw is retained in an advanced position tohelp open up the natural airway and alleviate theuser’s snoring condition.• A breathing port at the front of the appliance with anenclosed airway on each side which passes betweenthe teeth and the cheek. Each airway delivers the airat the rear of the mouth typically between the lastteeth. The airways allow the user to breathe with themouth closed.
- Published
- 2019-05-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| LRK | Device, Anti-Snoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K160234 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09351567000004 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09351567000004 | 09351567000004 | 9351567000004 |
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
- 748034696
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 09351567000028 | O2Vent W | O2Vent W | 2019-04-30 | |
| 09351567000363 | O2Vent Optima | O2Vent Optima Mini | O2VBM | 2021-12-02 |
| 09351567000035 | O2Vent Optima | O2Vent Optima | 2020-01-03 | |
| 09351567000011 | O2Vent T | O2Vent T | 2019-04-30 |
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