O2Vent T - The O2Vent T is a removable medical device that - OVENTUS MANUFACTURING PTY LTD

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OVENTUS MANUFACTURING PTY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5