Dolphin

GUDID 07290016880311

The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/4D system can be used in hospitals, clinics and physician offices

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880311
• NIH Device Record Key: e1cc43a7-e410-4d31-ad42-73cafc472dd8
• Commercial Distribution Discontinuation: 2019-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Dolphin
• Version Model Number: 4D
• 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	07290016880311 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-21
• Device Publish Date: 2019-06-07

On-Brand Devices [Dolphin]

• 07290016880045: The Dolphin/IQ is a medical Doppler device intended for noninvasive measurements of blood flow v
• 07290016880038: The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow v
• 07290016880328: The Dolphin/IQ is a medical Doppler device intended for noninvasive measurements of blood flow v
• 07290016880311: The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow v
• 07290016880212: The Dolphin/MAX is a medical Doppler device intended for noninvasive measurements of blood flow