Vitazi.ai Telehealth Portal

GUDID 00860012221608

Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images.

Vitazi.Ai, Inc.

Medical image management system

• Primary Device ID: 00860012221608
• NIH Device Record Key: e9c7e939-6a00-43dd-a02e-265021f28fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitazi.ai Telehealth Portal
• Version Model Number: 0.0.8
• Company DUNS: 118897923
• Company Name: Vitazi.Ai, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00860012221608 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2024-09-20
• Device Publish Date: 2024-09-12