Xavant Technology XT-45021D

GUDID 16009880396785

Quantitative NMT Monitor

XAVANT TECHNOLOGY (PTY) LTD

Diagnostic peripheral nerve electrical stimulation system

• Primary Device ID: 16009880396785
• NIH Device Record Key: b73bf884-1981-4e3c-865c-2433d7fc9226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xavant Technology
• Version Model Number: STIMPOD NMS450 AMG Only Kit (1.8m)
• Catalog Number: XT-45021D
• Company DUNS: 639571707
• Company Name: XAVANT TECHNOLOGY (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009880396788 [Primary]
GS1	16009880396785 [Package]; Contains: 06009880396788; Package: Box [1 Units]; In Commercial Distribution
GS1	26009880396782 [Package]; Contains: 06009880396788; Package: Box [2 Units]; In Commercial Distribution
GS1	36009880396789 [Package]; Contains: 06009880396788; Package: Box [3 Units]; In Commercial Distribution
GS1	46009880396786 [Package]; Contains: 06009880396788; Package: Box [4 Units]; In Commercial Distribution
GS1	56009880396783 [Package]; Contains: 06009880396788; Package: Box [5 Units]; In Commercial Distribution
GS1	66009880396780 [Package]; Contains: 06009880396788; Package: Box [10 Units]; In Commercial Distribution
GS1	76009880396787 [Package]; Contains: 06009880396788; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102084

FDA Product Code

• BXN: Stimulator, Nerve, Battery-Powered

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: 2021-08-26
• Device Publish Date: 2021-08-18

On-Brand Devices [Xavant Technology]

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• 46009880396342: Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
• 46009880396335: Neuromuscular blocking agent monitoring cable (1.8 m) with three dimensional acceleromyography.
• 36009880396321: The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathw
• 46009880396311: The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathw
• 46009880396243: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
• 06009880396160: Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
• 46009880396151: Neuromuscular blocking agent monitoring cable (1.5m) with three-dimensional acceleromyography.
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• 46009880396137: The STIMPOD NMS450 is a precision nerve locating tool used for localizing specific neural pathwa
• 06009880396085: This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector
• 06009880396078: The STIMPOD NMS 410 is a precision nerve locating tool used for localizing specific neural pathw
• 06009880396030: Nerve mapping cable for NMS460.
• 06009880396023: The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathway
• 16009880396785: Quantitative NMT Monitor
• 06009880396832: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
• 06009880396825: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
• 06009880396870: The STIMPOD NMS450 is a Quantitative Neuromuscular Blockade monitor. The STIMPOD NMS 450 is als