Digital NeuroPort Biopotential Signal Processing System 12125

GUDID 00814901021534

Gemini Neural Signal Processor

BLACKROCK MICROSYSTEMS, LLC

Electroencephalographic signal amplifier

• Primary Device ID: 00814901021534
• NIH Device Record Key: 63039de2-f187-4f76-8b86-b67d6bd28691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital NeuroPort Biopotential Signal Processing System
• Version Model Number: 12125
• Catalog Number: 12125
• Company DUNS: 827132015
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• 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: 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

Customer Support Contacts

• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com
• Phone: 8015825533
• Email: mtrebella@blackrockneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901021435 [Previous]
GS1	00814901021534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202174

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2023-12-12
• Device Publish Date: 2023-12-04

On-Brand Devices [Digital NeuroPort Biopotential Signal Processing System]

• 00814901021404: Digital Hub
• 00814901021398: Non-Sterile Digital Data Cable 1.5m
• 00814901021381: Non-Sterile NeuroPlex E128 Digital Headstage
• 00814901021374: Non-Sterile NeuroPlex E96 Digital Headstage
• 00814901021367: Sterile Digital Data Cable 1.5m
• 00814901021350: Sterile NeuroPlex E128 Digital Headstage
• 00814901021343: Sterile NeuroPlex E96 Digital Headstage
• 00814901021442: Gemini Hub Neural Signal Processor
• 00814901021435: Gemini Neural Signal Processor
• 00814901021534: Gemini Neural Signal Processor
• 00814901021527: Gemini Hub Neural Signal Processor