Home GUDID 08057971592739 Myo Unit
Primary DI 08057971592739
Brand Myo Unit
Company BIONIT LABS SRL
Model MU01-01
Device description Device for displaying surface EMG signal intensity from active electrodes
Published 2024-11-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HCJ Device, Skin Potential Measurement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCJ Device, Skin Potential Measurement Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08057971592739 Package GS1 1 In Commercial Distribution 08057971591053 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08057971592739 08057971592739 8057971592739 08057971591053 08057971591053 8057971591053
GMDN Terms# Term, Definition table Term Definition Electromyograph An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 45 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature -10 Degrees Celsius 35 Degrees Celsius Storage Environment Humidity 45 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 439080477 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08057971591053 Myo Unit BIONIT LABS SRL HCJ 2024-11-13 06975980570000 MEICET Shanghai May Skin Information Technology Co., Ltd. HCJ 2023-01-30 06975980570017 MEICET Shanghai May Skin Information Technology Co., Ltd. HCJ 2023-01-28
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