V-Universal Stand

GUDID 00841517100063

Diagnostic Ultrasound System Accessory

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517100063
• NIH Device Record Key: 824dcdba-eb60-4382-a1ee-28bbd1ed34e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Universal Stand
• Version Model Number: P12738-31
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102390

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: 2016-09-12

On-Brand Devices [V-Universal Stand]

• 00841517102166: Diagnostic Ultrasound System Accessory
• 00841517102128: Diagnostic Ultrasound System Accessory
• 00841517102050: Diagnostic Ultrasound System Accessory
• 00841517101749: Diagnostic Ultrasound System Accessory
• 00841517100063: Diagnostic Ultrasound System Accessory
• 00841517105778: Diagnostic Ultrasound System Accessory