O2Vent W

GUDID 09351567000028

The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent W is made up of two parts: 1. The Upper Tray fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.

OVENTUS MANUFACTURING PTY LTD

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 09351567000028
• NIH Device Record Key: c597d572-e62e-4ab2-af6a-670f13c0e997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2Vent W
• Version Model Number: O2Vent W
• Company DUNS: 748034696
• Company Name: OVENTUS MANUFACTURING PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-835-0116
• Email: support@oventusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351567000028 [Primary]

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-08
• Device Publish Date: 2019-04-30

Devices Manufactured by OVENTUS MANUFACTURING PTY LTD

• 09351567000363 - O2Vent Optima: 2021-12-10 The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or allevia
• 09351567000035 - O2Vent Optima: 2020-01-13 The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate s
• 09351567000004 - O2Vent Mono (OVENT): 2019-06-07 The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of: • A titanium bimaxillary
• 09351567000011 - O2Vent T: 2019-05-08 The O2Vent T is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snorin
• 09351567000028 - O2Vent W: 2019-05-08The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent W is made up of two parts: 1. The Upper Tray fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.
• 09351567000028 - O2Vent W: 2019-05-08 The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (O