AccessGUDID - DEVICE: X-Series (00851113007918)

GUDID

Device Identifier (DI) Information

Brand Name: X-Series
Version or Model: ES31-1001, ES31-1003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED BRAIN MONITORING, INC.

Primary DI Number: 00851113007918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969842715 *Terms of Use

Device Description: External Syncing Unit - Multi-Channel Kit (PAN 1026A)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	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?
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWQ	Full-Montage Standard Electroencephalograph
OMC	Reduced- Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131383	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: 0f9f274e-3f3e-4d74-87ee-b5bf7de5dd1c
Public Version Date: November 10, 2021
Public Version Number: 2
DI Record Publish Date: August 21, 2018