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 table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161832000O2VENT TOventus Manufacturing Pty, Ltd.2016-09-23LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351567000011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351567000011093515670000119351567000011

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-835-0116support@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 table
Primary DIBrandModelCatalogPublished
09351567000028O2Vent WO2Vent W2019-04-30
09351567000363O2Vent OptimaO2Vent Optima MiniO2VBM2021-12-02
09351567000035O2Vent OptimaO2Vent Optima2020-01-03
09351567000004O2Vent Mono (OVENT)O2Vent Mono2019-05-30

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