AccessGUDID - DEVICE: STIMPOD X-LINK (06009880396610)

GUDID

Device Identifier (DI) Information

Brand Name: STIMPOD X-LINK
Version or Model: XT-45300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XT-45300
Company Name: XAVANT TECHNOLOGY (PTY) LTD

Primary DI Number: 06009880396610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 639571707 *Terms of Use

Device Description: The X-Link is intended to transmit data collected by the STIMPOD devices during NMT monitoring to a hospital's EMR (Electronic Medical Records) system via the hospital's network. This facilitates seamless integration of patient monitoring data into the hospital’s digital records, improving workflow efficiency and reducing manual entry errors. Additionally, the X-Link provides the capability to charge the STIMPOD NMS450X+ device when not in use (STIMPOD not in clinical use) and is disconnected from the patient, enhancing workflow efficiency in its operating environment. The product does not control any functionality of the STIMPOD devices.

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
OUG	Medical Device Data System

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db8ec82b-d48c-4371-8303-cadec059f8fc
Public Version Date: August 07, 2025
Public Version Number: 1
DI Record Publish Date: July 30, 2025