2 MHz monitoring

GUDID 07290016880304

2 MHz monitoring probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880304
• NIH Device Record Key: 15ac0db9-ef49-4e29-b094-1c9e3dab3330
• Commercial Distribution Discontinuation: 2019-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 2 MHz monitoring
• Version Model Number: 2 MHz monitoring , 5 meter cable
• Company DUNS: 533070236
• Company Name: VIASONIX 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	07290016880304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191023

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2019-06-17
• Device Publish Date: 2019-06-07

On-Brand Devices [2 MHz monitoring ]

• 07290016880106: 2 MHz monitoring probe is an ultrasonic transducer which generate acoustic signals and also dete
• 07290016880304: 2 MHz monitoring probe is an ultrasonic transducer which generate acoustic signals and also dete