IDx-DR

GUDID 00860005195619

Digital Diagnostics Inc.

Automated retinopathy analysis system application software

• Primary Device ID: 00860005195619
• NIH Device Record Key: 64501863-533c-4c61-a690-93e53af716ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDx-DR
• Version Model Number: V2
• Company DUNS: 028582271
• Company Name: Digital Diagnostics Inc.
• 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: true
• 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	00860005195619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203629

FDA Product Code

• PIB: Diabetic Retinopathy Detection Device

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: 2021-07-19
• Device Publish Date: 2021-07-09

On-Brand Devices [IDx-DR]

• 00860005195619: V2
• 00860005195626: v2.3