Vivos mmRNA

GUDID 00810106971452

The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.

Aurum Group Ltd

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00810106971452
• NIH Device Record Key: 78e4a7d3-abdf-4dbf-b730-9d1a1df172e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivos mmRNA
• Version Model Number: 5.016
• Company DUNS: 243286441
• Company Name: Aurum Group 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	00810106971452 [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: 2023-09-29
• Device Publish Date: 2023-09-21

Devices Manufactured by Aurum Group Ltd

• 00810106971438 - Vivos mRNA: 2023-10-03 An intraoral device for the treatment of snoring and mild to moderate obstructive sleep apnea in adults.
• 00810106971445 - Vivos DNA: 2023-10-03 The Vivos appliance is an adult palate expander used to treat adults who clench their teeth, have TMJ pain, and sleep apnea.
• 00810106971452 - Vivos mmRNA: 2023-09-29The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.
• 00810106971452 - Vivos mmRNA: 2023-09-29 The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate snoring and mild to moderate sleep apn