DuoMAG NL DM-NL

GUDID 08592566001055

The DuoMAG NL is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain. DuoMAG NL consists of a Magnetic stimulator DuoMAG XT-NL, stimulation coil, trolley MagCart, and LiquidCool System unit.

DEYMED Diagnostic s.r.o.

Magnetic neural stimulation system, mobile

• Primary Device ID: 08592566001055
• NIH Device Record Key: 4b0bc2ab-fdbd-4898-864d-9d339342e05d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuoMAG NL
• Version Model Number: DM-NL
• Catalog Number: DM-NL
• Company DUNS: 495566056
• Company Name: DEYMED Diagnostic s.r.o.
• 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: 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

Customer Support Contacts

• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592566001055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210021

FDA Product Code

• QPL: Electromagnetic Stimulator, Pain Relief

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: 2021-07-07
• Device Publish Date: 2021-06-29

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• 08592566471506 - Magnetic stimulator DuoMAG XT-NL: 2023-11-03 47-150