VascuLab

GUDID 00861446000401

US VASCULAR LLC

Noninvasive vascular ultrasound system, line-powered

• Primary Device ID: 00861446000401
• NIH Device Record Key: d8b00c75-9ee5-4125-9110-aed9b5c2956d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VascuLab
• Version Model Number: 4040
• Company DUNS: 062635760
• Company Name: US VASCULAR LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 800 326 1169
• Email: help@VascuLab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861446000401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131860

FDA Product Code

• JOP: Transducer, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-15