STIMPOD X-LINK XT-45300

GUDID 06009880396610

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.

XAVANT TECHNOLOGY (PTY) LTD

Medical networking interface unit

• Primary Device ID: 06009880396610
• NIH Device Record Key: db8ec82b-d48c-4371-8303-cadec059f8fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STIMPOD X-LINK
• Version Model Number: XT-45300
• Catalog Number: XT-45300
• Company DUNS: 639571707
• Company Name: XAVANT TECHNOLOGY (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009880396610 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by XAVANT TECHNOLOGY (PTY) LTD

• 06009880396443 - BIOVENTUS: 2025-08-07 The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrod
• 06009880396610 - STIMPOD X-LINK: 2025-08-07The 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.
• 06009880396610 - STIMPOD X-LINK: 2025-08-07 The X-Link is intended to transmit data collected by the STIMPOD devices during NMT monitoring to a hospital's EMR (Electronic M
• 06009880396184 - BIONESS: 2025-02-25 The STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous elec
• 06009880396191 - BIONESS: 2025-02-25 The adapter cable is connected to the ST2-3000 nerve stimulation device for deploying electrical stimulations .
• 06009880396177 - STIMPOD: 2024-11-25 Neuromuscular blocking agent monitoring cable (3.0m) using electromyography. Accessory to be used with the STIMPOD NMS450 Nerve
• 06009880396429 - STIMPOD: 2024-11-25 Neuromuscular blocking agent monitoring cable (3.0m) using acceleromyography. Accessory to be used with the STIMPOD NMS450 Nerve
• 06009880396870 - Xavant Technology: 2024-01-01 The STIMPOD NMS450 is a Quantitative Neuromuscular Blockade monitor. The STIMPOD NMS 450 is also a precision nerve locating too
• 06009880396825 - Xavant Technology: 2023-11-20 The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulation device, used for symptomatic r