O2Vent T
- Primary DI
- 09351567000011
- Brand
- O2Vent T
- Company
- OVENTUS MANUFACTURING PTY LTD
- Model
- O2Vent T
- Device description
- "The O2Vent T is a removable medical device that is fitted in thepatient’s mouth and is intended to reduce or alleviate snoringand mild to moderate obstructive sleep apnea (OSA).The O2Vent T is made up of three parts:1. The Upper Tray fitted over the upper teeth, with the breathingport at the front leading to the airways on each side to the rear ofthe appliance, is made from medical grade titanium2. The Lower Tray fitted over the lower teeth, positions the jawfor mandibular advancement.The Upper and Lower Trays have a ""landing area” customized tothe patientsteeth and made from medical grade polymers. 3. The Upper and Lower Trays are connected together with aconnector. A hook mechanism attached to the Upper Tray fitsinto a socket attached to the Lower Tray and positions the lowerjaw forward, preventing the soft tissue of the throat fromcollapsing and obstructing the airway. An Adjustment Key forthe O2Vent T allows the patient and their Clinician to adjust theprotrusion of the lower jaw to the most effective andcomfortable position."
- Published
- 2019-04-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Contact Domains#
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 |
|---|---|
| K161832 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09351567000011 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09351567000011 | 09351567000011 | 9351567000011 |
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 |
|---|
Contacts#
| Phone | |
|---|---|
| 1-866-835-0116 | support@oventusmedical.com |
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 | |
| 09351567000004 | O2Vent Mono (OVENT) | O2Vent Mono | 2019-05-30 |
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