X-Series, X8

GUDID 00851113007833

Bluetooth Dongle - PAN 1026

ADVANCED BRAIN MONITORING, INC.

Medical networking interface unit

• Primary Device ID: 00851113007833
• NIH Device Record Key: da2c66e5-15d6-473b-b0e0-15f862cce2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Series, X8
• Version Model Number: 31-1003, 31-1004
• 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	00851113007833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131383

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-11

On-Brand Devices [X-Series, X8]

• 00851113007833: Bluetooth Dongle - PAN 1026
• 00851113007260: Bluetooth Dongle
• 00851113007161: Dual Lead Cable 20" Kit
• 00850015266584: Dual Lead Cable 40" 3-Pin Kit Italian
• 00850015266577: Arm & Chin EMG Cable Kit Italian
• 00850015266560: Arm & Chin EMG Cable Kit
• 00850015266553: Dual Lead Cable 40" 3-Pin Kit
• 00850015266805: Dual Lead Cable 40" 3-Pin Kit Polish
• 00850015266836: Arm & Chin EMG Cable Kit Polish