AccessGUDID - DEVICE: VitalEEG Portable System (00841983104282)

GUDID

Device Identifier (DI) Information

Brand Name: VitalEEG Portable System
Version or Model: AE-120A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AE-120A
Company Name: NIHON KOHDEN AMERICA, INC.

Primary DI Number: 00841983104282
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021063219 *Terms of Use

Device Description: Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition System.

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
OMC	Reduced- Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 34ebe215-3b58-424c-93f8-01188bfc6c2e
Public Version Date: April 15, 2024
Public Version Number: 4
DI Record Publish Date: March 29, 2021