MyLabX8 eXP

GUDID 08056304454126

ESAOTE SPA

General-purpose ultrasound imaging system

• Primary Device ID: 08056304454126
• NIH Device Record Key: 3f1a787d-8efb-4b81-92cb-4d4d3187e13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyLabX8 eXP
• Version Model Number: 100645010
• Company DUNS: 437384304
• Company Name: ESAOTE SPA
• 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	08056304454126 [Primary]

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-25
• Device Publish Date: 2019-12-20

Devices Manufactured by ESAOTE SPA

• 08056304455017 - MyLabA50: 2025-07-15
• 08056304455062 - 2CWL: 2025-07-15
• 08056304455079 - 5CWL: 2025-07-15
• 08056304455215 - MyLabE85: 2025-07-15
• 08056304455222 - P 1-5E: 2025-07-15
• 08056304455239 - C 1-8E: 2025-07-15
• 08056304455307 - MyLabA70: 2025-07-15
• 08056304455383 - L 3-15E: 2025-07-15