Digital NeuroPort Biopotential Signal Processing System 11404

GUDID 00814901021398

Non-Sterile Digital Data Cable 1.5m

BLACKROCK MICROSYSTEMS, LLC

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 00814901021398
• NIH Device Record Key: 10369f5a-5e57-4b96-b04a-b12f8b48ea63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital NeuroPort Biopotential Signal Processing System
• Version Model Number: 11404
• Catalog Number: 11404
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901021398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202174

FDA Product Code

• GWK: Conditioner, Signal, Physiological

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: 2021-07-09
• Device Publish Date: 2021-07-01

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

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• 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