AccessGUDID - DEVICE: NA (00851725007092)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: CGS-9001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CGS-9001
Company Name: Nihon Kohden Digital Health Solutions, LLC

Primary DI Number: 00851725007092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126381560 *Terms of Use

Device Description: Communication Gateway Server CGS-9001 (Pager Commnunication Gateway Server)

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
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083271	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 898de94f-4e7e-459e-98fc-55e9dbbc1bb9
Public Version Date: January 29, 2025
Public Version Number: 6
DI Record Publish Date: October 03, 2016