NeuroSENSE

GUDID B746NS90101

Neurowave Systems Inc.

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• Primary Device ID: B746NS90101
• NIH Device Record Key: b63c7576-63c1-44af-b655-5a9594a58f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroSENSE
• Version Model Number: NS-901
• Company DUNS: 607075160
• Company Name: Neurowave Systems Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
HIBCC	B746NS90101 [Primary]

FDA Product Code

• OLW: Index-Generating Electroencephalograph Software

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: 2022-10-31
• Device Publish Date: 2022-10-21

Devices Manufactured by Neurowave Systems Inc.

• B746EK9011 - EasyPrep Sensor Kit: 2023-11-10
• B746NS90101 - NeuroSENSE: 2022-10-31
• B746NS90101 - NeuroSENSE: 2022-10-31