X-Series

Basic Information

• Brand Name: X-Series
• Primary DI: 00850015266614
• Version / Model: XS30-4301
• Company Name: ADVANCED BRAIN MONITORING, INC.
• Labeler DUNS: 969842715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-09
• Public Version: 1
• Public Version Date: 2022-11-17
• Public Version Status: New
• Public Device Record Key: 89b01f97-0317-4e7c-8bb6-6f6190ff1275

Device Description

Single-Use Strip Sensor Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37323	Patient monitoring system module, electroencephalographic	A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850015266614	GS1

Premarket Submissions

Submission Number	Supplement Number
K131383	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 7 – 20 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 7 – 20 Degrees Celsius