Blackrock NeuroPort Biopotential Signal Processing System RS-0049, RS-0152

GUDID 00814901021459

NeuroPort Central Suite

BLACKROCK MICROSYSTEMS, LLC

Bioelectrical signal analysis software

• Primary Device ID: 00814901021459
• NIH Device Record Key: 6d4e1b31-4481-4967-8da8-70282c80037f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blackrock NeuroPort Biopotential Signal Processing System
• Version Model Number: 7.5.2
• Catalog Number: RS-0049, RS-0152
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901021459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090957

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: 2022-10-05
• Device Publish Date: 2022-09-27

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

• 00814901020315: NeuroPort Central Suite
• 00814901020308: NeuroPort Central Suite
• 00814901020292: NeuroPort Central Suite
• 00814901020285: Neural Signal Processor II
• 00814901020278: NeuroPort Central Suite
• 00814901020261: 16 Ch Macro Cabrio Butterfly Adapter
• 00814901020254: 16 Ch Cabrio Butterfly Adapter
• 00814901020247: NeuroPort Neural Signal Amplifier Case
• 00814901020230: 32 Ch Cabrio Butterfly Ref Adapter
• 00814901020223: 64 Channel Splitter Box Ch 65-128
• 00814901020216: 64 Channel Splitter Box
• 00814901020209: Digital Neural Signal Simulator
• 00814901020193: NeuroPort Central Suite
• 00814901020186: Amplifier Manifold
• 00814901020179: Amplifier Power Supply
• 00814901020162: NeuroPort Neural Signal Amplifier 32 Ch
• 00814901020155: NeuroPort Neural Signal Amplifier 64 Ch
• 00814901020148: NeuroPort Neural Signal Amplifier 96 Ch
• 00814901020131: NeuroPort Neural Signal Amplifier 128 Ch
• 00814901020124: Neural Signal Processor
• 00814901020117: Patient Cable with Filament Film
• 00814901020100: Patient Cable with Impedance Tester
• 00814901021428: NeuroPort Central Suite
• 00814901021459: NeuroPort Central Suite
• 00814901021466: NeuroPort Central Suite
• 00814901021497: NeuroPort Central Suite
• 00814901021558: NeuroPort Central Suite