Component Neuromonitoring System

GUDID 00382830063005

International (non-U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

NATUS NEUROLOGY INCORPORATED

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• Primary Device ID: 00382830063005
• NIH Device Record Key: aac3731a-74d4-4afe-9ef9-e58eb61162e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Component Neuromonitoring System
• Version Model Number: CNS-320
• Company DUNS: 874257488
• Company Name: NATUS NEUROLOGY INCORPORATED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00382830063005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080217

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2023-08-22
• Device Publish Date: 2023-08-14

On-Brand Devices [Component Neuromonitoring System]

• 00382830063029: International (non-U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and
• 00382830063012: Domestic (U.S.) model; optional camera that can be used to record video of the patient.
• 00382830063005: International (non-U.S.) model; a portable, computer-based system that can continuously record,
• 00382830062985: Optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from
• 00382830062961: A portable, computer-based system that can continuously record, display, store and analyze physi
• 00382830062954: Optional camera that can be used to record video of the patient.
• 00382830062947: Optional camera that can be used to record video of the patient.