Ventripoint Medical System Plus (VMS+)

GUDID 07540263000018

The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images

VentriPoint Diagnostics Ltd

Radiology picture archiving and communication system workstation

• Primary Device ID: 07540263000018
• NIH Device Record Key: 43d001bc-a737-45c4-8563-a2ac81afdfcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventripoint Medical System Plus (VMS+)
• Version Model Number: 2.0
• Company DUNS: 243131807
• Company Name: VentriPoint Diagnostics Ltd
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540263000018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173810

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: 2018-12-10
• Device Publish Date: 2018-11-07