ATLAS Ground Drive

Basic Information

• Brand Name: ATLAS Ground Drive
• Primary DI: 00850011306185
• Version / Model: Active Ground Drive
• Catalog Number: 31-0604-0100
• Company Name: NEURALYNX, INC.
• Labeler DUNS: 933200842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-19
• Public Version: 1
• Public Version Date: 2022-09-27
• Public Version Status: New
• Public Device Record Key: 27a3fba4-68da-492d-9d77-0e2b4bef4bf5

Device Description

The Active Ground Drive generates the Active Ground signal based on input selected in the Data Acquisition Software.

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: Yes
• 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
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35196	Electroencephalographic monitoring system, stationary	A mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological parameters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is a stationary device and commonly used at the patient's bedside, in an intensive care unit (ICU), or in a dedicated EEG monitoring room.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011306185	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110967	000