micromed

GUDID 08033928120910

The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) . The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals.

MICROMED SPA

Electroencephalograph

• Primary Device ID: 08033928120910
• NIH Device Record Key: 4951d11a-59c4-42c0-9ae9-40a7cfcda391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: micromed
• Version Model Number: BRAIN QUICK
• Company DUNS: 856998166
• Company Name: MICROMED SPA
• 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: 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	08033928120910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171384

FDA Product Code

• OLV: Standard Polysomnograph With Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2018-03-21

On-Brand Devices [micromed]

• 08033928121207: LED PHOTIC POWER is the power supply adapter included in LED PHOTIC System. LED PHOTIC System i
• 08033928121184: LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG r
• 08033928120910: The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals su