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 ID08592566001055
NIH Device Record Key4b0bc2ab-fdbd-4898-864d-9d339342e05d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuoMAG NL
Version Model NumberDM-NL
Catalog NumberDM-NL
Company DUNS495566056
Company NameDEYMED Diagnostic s.r.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com
Phone+1 858 229 9218
Emailhello@neuralacemedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108592566001055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPLElectromagnetic Stimulator, Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-07
Device Publish Date2021-06-29

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