Vevo MD Imaging System 51476

GUDID 00841517100766

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517100766
• NIH Device Record Key: a9be8d44-11bf-4346-956e-868daa5972cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vevo MD Imaging System
• Version Model Number: 51476-10
• Catalog Number: 51476
• Company DUNS: 014438860
• Company Name: FUJIFILM SONOSITE, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-657-8118
• Email: ffss-service@fujifilm.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160674

FDA Product Code

• IYO: System, imaging, pulsed echo, 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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Vevo MD Imaging System]

• 00841517104726: Diagnostic ultrasound system
• 00841517103248: Diagnostic ultrasound system
• 00841517102548: Diagnostic ultrasound system
• 00841517102524: Diagnostic ultrasound system
• 00841517100766: Diagnostic ultrasound system
• 00841517100759: Diagnostic ultrasound system
• 00841517109790: Diagnostic ultrasound system
• 00841517110123: Diagnostic ultrasound system