AccessGUDID - DEVICE: BrainScope One (00852745007239)

GUDID

Device Identifier (DI) Information

Brand Name: BrainScope One
Version or Model: Ahead 500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSO-2001
Company Name: Brainscope Company, Inc.

Primary DI Number: 00852745007239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 805670416 *Terms of Use

Device Description: BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the BrainScope One Device.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLU	Normalizing Quantitative Electroencephalograph Software
PKQ	Computerized Cognitive Assessment Aid
PIW	Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190815	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18950102-9a45-4046-b875-6fd0aaddd32a
Public Version Date: September 27, 2023
Public Version Number: 3
DI Record Publish Date: February 16, 2021