Dolphin

GUDID 07290016880038

The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatri

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880038
• NIH Device Record Key: f69618a2-5f21-4ac3-8dc1-af5b1c4363b7
• Commercial Distribution Discontinuation: 2017-12-24
• 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	07290016880038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170859

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-17

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