X8

GUDID 00851113007185

External Battery Custom Cable Kit

ADVANCED BRAIN MONITORING, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00851113007185
• NIH Device Record Key: e99c56db-d44f-4506-a64d-76a0b71645a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X8
• Version Model Number: UN03-5204
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00851113007185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152040

FDA Product Code

• OLV: Standard Polysomnograph With 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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