Remote Monitoring System 36-0301-0002

GUDID 00850011306680

Electroencephalographic monitoring system, stationary

Primary Device ID	00850011306680
NIH Device Record Key	3a636138-89ec-41b3-923f-2e7d654beae5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Remote Monitoring System
Version Model Number	1.0.0
Catalog Number	36-0301-0002
Company DUNS	933200842
Company Name	NEURALYNX, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	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

Device Issuing Agency	Device ID
GS1	00850011306680 [Primary]

OMC	Reduced- Montage Standard Electroencephalograph

Steralize Prior To Use	false
Device Is Sterile	false

00850011306338 - ATLAS Stim Headbox - Touchproof	2025-06-19 ATLAS Stim Headbox with Touchproof side panel.
00850011306345 - ATLAS Stim Headbox - High Density	2025-06-19 ATLAS Stim Headbox with High Density side panel.
00850011306703 - ATLAS Stim Headbox Software	2025-06-19 Control software for the ATLAS Stim Headbox.
00850011306710 - Fiber Optic Connector 2m	2025-06-19 Computer ethernet connection; 2m in length.
00850011306727 - Fiber Optic Connector 7m	2025-06-19 Computer ethernet connection; 7m in length.
00850011306901 - ATLAS Headbox Interface Cable - Touchproof	2025-06-19 Cable to connect 100-pin Hirose connector to Touchproof pins.
00850011306918 - ATLAS Headbox Interface Cable - NK	2025-06-19 Cable to connect 100-pin Hirose connector to NK connector.
00850011306925 - ATLAS Headbox Interface Cable - High Density	2025-06-19 Cable to connect 100-pin Hirose connector to Natus connector.