OmniPro System 718-8300

GUDID B62571883000

OmniPro EEG System used in EEG physiological data collection

Mays & Asscoiates

Electroencephalograph

• Primary Device ID: B62571883000
• NIH Device Record Key: 6f5acac4-4075-4a9e-9734-5ece04185f86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniPro System
• Version Model Number: OmniPro EEG System
• Catalog Number: 718-8300
• Company DUNS: 101772069
• Company Name: Mays & Asscoiates
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net
• Phone: 6159732027
• Email: burke.mays@maysinc.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B62571883000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050143

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2019-12-17
• Device Publish Date: 2019-12-09

On-Brand Devices [OmniPro System]

• B62571884000: OmniPro PSG System used in PSG physiological data collection
• B62571883000: OmniPro EEG System used in EEG physiological data collection
• B62536084100: The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and el
• B62536084000: The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagn
• B62536083000: The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a