MyLabOne

GUDID 08056304453013

Soft. Version R20

Esaote Europe B.V.

General-purpose ultrasound imaging system

• Primary Device ID: 08056304453013
• NIH Device Record Key: b928f691-70b0-42f3-adb9-3f3d67534f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyLabOne
• Version Model Number: 102810019
• Company DUNS: 404392797
• Company Name: Esaote Europe B.V.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056304453013 [Primary]

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-12-15
• Device Publish Date: 2017-02-24

Devices Manufactured by Esaote Europe B.V.

• 08056304453013 - MyLabOne: 2025-12-15Soft. Version R20
• 08056304453013 - MyLabOne: 2025-12-15 Soft. Version R20
• 08056304453020 - MyLabSix: 2025-12-15 Ver. V2