MyLabE85

GUDID 08056304455642

ESAOTE SPA

General-purpose ultrasound imaging system

• Primary Device ID: 08056304455642
• NIH Device Record Key: dd9e7a6b-6ceb-49ac-90de-f269d62e834b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyLabE85
• Version Model Number: 100645084
• 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	08056304455642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241671

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-15
• Device Publish Date: 2025-07-07

On-Brand Devices [MyLabE85]

• 08056304455642: 100645084
• 08056304455215: 100645085