X-Series, X8

GUDID 00851113007260

Bluetooth Dongle

ADVANCED BRAIN MONITORING, INC.

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• Primary Device ID: 00851113007260
• NIH Device Record Key: 83fed772-bf62-446e-91ed-5671185318e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Series, X8
• Version Model Number: 31-1003
• Company DUNS: 969842715
• Company Name: ADVANCED BRAIN MONITORING, INC.
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00851113007260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131383

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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