Myo Unit

GUDID 08057971592739

Device for displaying surface EMG signal intensity from active electrodes

BIONIT LABS SRL

Electromyograph

• Primary Device ID: 08057971592739
• NIH Device Record Key: 80ee65e9-1c2f-4836-9761-27c3248a7b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myo Unit
• Version Model Number: MU01-01
• Company DUNS: 439080477
• Company Name: BIONIT LABS SRL
• 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: 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

Customer Support Contacts

• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057971591053 [Primary]
GS1	08057971592739 [Package]; Contains: 08057971591053; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• HCJ: Device, Skin Potential Measurement

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: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by BIONIT LABS SRL

• 08057971591725 - Adam's Skin: 2025-02-19 Adam's Skin - Glove for Adam's Hand (spare part) - Individual Glove - Side: Right - Size: Medium
• 08057971591374 - Adam's Skin: 2025-01-30 Adam's Skin - Glove for Adam's Hand (spare part) - Basic Glove - Color: N1 - Side: Right - Size: Medium
• 08057971591411 - Adam's Skin: 2025-01-30 Adam's Skin - Glove for Adam's Hand (spare part) - Basic Glove - Color: N3 - Side: Right - Size: Medium
• 08057971591718 - Adam's Skin: 2025-01-30 Adam's Skin - Glove for Adam's Hand (spare part) - Individual Glove - Side: Left- Size: Medium
• 08057971592975 - Adam's Skin: 2025-01-30 Adam's Skin - Glove for Adam's Hand (spare part) - Patriot pattern - Side: Left- Size: Medium
• 08057971592999 - Adam's Skin: 2025-01-30 Adam's Skin - Glove for Adam's Hand (spare part) - Scorpion pattern - Side: Left- Size: Medium
• 08057971593019 - Adam's Skin: 2025-01-30 Adam's Skin - Glove for Adam's Hand (spare part) - Hunter pattern - Side: Left- Size: Medium
• 08057971590964 - Wave Electrode with accessories: 2025-01-29 Wave Electrode, 60 Hz with accessories - cable length 30 cm