BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

X-Series

DI: 00850063034166 · Model: XS30-1001.LE · ADVANCED BRAIN MONITORING, INC.

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Product Codes

2

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: X-Series
Primary DI: 00850063034166
Version / Model: XS30-1001.LE
Company Name: ADVANCED BRAIN MONITORING, INC.
Labeler DUNS: 969842715
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-01-29
Public Version: 1
Public Version Date: 2025-02-06
Public Version Status: New
Public Device Record Key: 1109740b-27f7-40ac-96d0-a7404cf697ae

Device Description

Stat X24 LE Device Kit

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	00850063034166	GS1

Premarket Submissions

Submission Number	Supplement Number
K131383	000

Storage Conditions

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