X-Series

Basic Information

• Brand Name: X-Series
• Primary DI: 00850015266348
• Version / Model: XS30-1007
• Company Name: ADVANCED BRAIN MONITORING, INC.
• Labeler DUNS: 969842715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-26
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: f294cc68-fbfc-4450-8de7-1b846a49155a

Device Description

X24 Stat System Kit Clinical

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
11467	Electroencephalograph	An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850015266348	GS1
Direct Marking	00851113007345	GS1

Premarket Submissions

Submission Number	Supplement Number
K131383	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal