MyLabE80

GUDID 08056304455628

ESAOTE SPA

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 08056304455628
• NIH Device Record Key: 645cbaf4-1f2f-4b93-b140-4d5d24f52e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyLabE80
• Version Model Number: 100645082
• 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	08056304455628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192157

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: 2024-04-08
• Device Publish Date: 2024-03-29

Devices Manufactured by ESAOTE SPA

• 08056304455628 - MyLabE80: 2024-04-08
• 08056304455628 - MyLabE80: 2024-04-08
• 08056304454287 - PX 1-5: 2023-12-22
• 08056304454614 - 2CWS-L: 2023-12-22
• 08056304454621 - 5CWS-L: 2023-12-22
• 08056304454812 - TE 3-8: 2023-12-22
• 08056304454836 - CX 1-8: 2023-12-22
• 08056304454935 - LMX 4-20: 2023-12-22
• 08056304454980 - MyLabX90: 2023-12-22