Digital NeuroPort Biopotential Signal Processing System

Basic Information

• Brand Name: Digital NeuroPort Biopotential Signal Processing System
• Primary DI: 00814901021527
• Version / Model: 12126
• Catalog Number: 12126
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• Labeler DUNS: 827132015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-04
• Public Version: 1
• Public Version Date: 2023-12-12
• Public Version Status: New
• Public Device Record Key: 9e0cf7fb-6f4d-4612-a0bc-b82fe0618604

Device Description

Gemini Hub Neural Signal Processor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWL	Amplifier, Physiological Signal	Neurology	882.1835	2
GWK	Conditioner, Signal, Physiological	Neurology	882.1845	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36740	Electroencephalographic signal amplifier	An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814901021527	GS1
Previous	00814901021442	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K202174	000