O2Vent Mono (OVENT)

GUDID 09351567000004

The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of: • A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth. • A dental polymer material in each tray which is in contact with and retaining in position, the user’s top and bottom teeth. • The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user’s snoring condition. • A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.

OVENTUS MANUFACTURING PTY LTD

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 09351567000004
• NIH Device Record Key: 1393c5db-a0e2-40d8-b08b-6ba705de6b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2Vent Mono (OVENT)
• Version Model Number: O2Vent Mono
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351567000004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160234

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: 2019-06-07
• Device Publish Date: 2019-05-30

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): 2019-06-07The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of: • A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth. • A dental polymer material in each tray which is in contact with and retaining in position, the user’s top and bottom teeth. • The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user’s snoring condition. • A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.
• 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: 2019-05-08 The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (O