JointVue 3D Echo

GUDID 00850014885021

JOINTVUE, LLC

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• Primary Device ID: 00850014885021
• NIH Device Record Key: d5413772-3589-4f5c-8f1c-089c441c2dd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JointVue 3D Echo
• Version Model Number: 1.0
• Company DUNS: 117090348
• Company Name: JOINTVUE, 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: false
• Manufacturing Date: false
• 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	00850014885021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173329

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-02-10
• Device Publish Date: 2020-01-31

On-Brand Devices [JointVue 3D Echo]

• 00850014885021: 1.0
• 00850014885007: 1.0