Digital NeuroPort Biopotential Signal Processing System 12126

GUDID 00814901021527

Gemini Hub Neural Signal Processor

BLACKROCK MICROSYSTEMS, LLC

Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier Electroencephalographic signal amplifier

• Primary Device ID: 00814901021527
• NIH Device Record Key: 9e0cf7fb-6f4d-4612-a0bc-b82fe0618604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital NeuroPort Biopotential Signal Processing System
• Version Model Number: 12126
• Catalog Number: 12126
• 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	00814901021442 [Previous]
GS1	00814901021527 [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