O2Vent Optima

GUDID 09351567000035

The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.

OVENTUS MANUFACTURING PTY LTD

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 09351567000035
• NIH Device Record Key: b5791608-232f-46c4-8496-f802f092f1ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2Vent Optima
• Version Model Number: O2Vent Optima
• Company DUNS: 748034696
• Company Name: OVENTUS MANUFACTURING PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	09351567000035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190236

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: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [O2Vent Optima]

• 09351567000035: The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is i
• 09351567000363: The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and