Duns Number:748034696
Device Description: The O2Vent T is a removable medical device that is fitted in thepatient’s mouth and is int 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.
Catalog Number
-
Brand Name
O2Vent T
Version/Model Number
O2Vent T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161832
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
e90e573e-ccb7-443e-8d05-3800c792d054
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |