Blackrock NeuroPort Biopotential Signal Processing System RS-0049

GUDID 00814901020193

NeuroPort Central Suite

BLACKROCK MICROSYSTEMS, LLC

Bioelectrical signal analysis software Bioelectrical signal analysis software

• Primary Device ID: 00814901020193
• NIH Device Record Key: ed4a9cd3-71ba-4d79-b2d3-2b1e8cce2f9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blackrock NeuroPort Biopotential Signal Processing System
• Version Model Number: 6.5.4
• Catalog Number: RS-0049
• 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: true
• Serial Number: false
• 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: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901020193 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-23

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