AccessGUDID - DEVICE: OmniPro System (B62536083000)

GUDID

Device Identifier (DI) Information

Brand Name: OmniPro System
Version or Model: OmniAmp EEG Module
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 360-8300
Company Name: Mays & Asscoiates

Primary DI Number: B62536083000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101772069 *Terms of Use

Device Description: The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a hospital or diagnostic center.

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):	No
Over the Counter (OTC):	No
Kit:	No
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
GWQ	Full-Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050143	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
Weight: 675 Gram
Height: 3.8 Centimeter
Width: 15.5 Centimeter
Length: 20.5 Centimeter

Device Record Status

Public Device Record Key: 79d607cb-2483-48cf-a4a8-8d6e298d1b97
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: December 09, 2019