NeuroCatch Platform NCEB

GUDID G134NCEB1

Earbuds used for the NeuroCatch Platform (REF NCP2)

NeuroCatch Inc

Electroencephalograph

• Primary Device ID: G134NCEB1
• NIH Device Record Key: 36d7ca30-eac6-4222-b1e0-fa8e4cebb780
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroCatch Platform
• Version Model Number: 2.0
• Catalog Number: NCEB
• Company DUNS: 203694427
• Company Name: NeuroCatch 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G134NCEB1 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

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: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [NeuroCatch Platform]

• G134NS200: NeuroCatch Platform software NS20
• G134NCP21: NeuroCatch Platform system REF: NCP2
• G134NCEB1: Earbuds used for the NeuroCatch Platform (REF NCP2)
• G134NCCP1: EEG Cap used for the NeuroCatch Platform Sizes SML, MED, LRG.