IDx-DR

GUDID 00860005195626

Digital Diagnostics Inc.

Retinal image analysis software

• Primary Device ID: 00860005195626
• NIH Device Record Key: bc71d3b5-a68f-44a4-89d6-f0370f07adaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDx-DR
• Version Model Number: v2.3
• 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: false
• Serial Number: false
• 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	00860005195626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213037

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: 2022-07-05
• Device Publish Date: 2022-06-27

On-Brand Devices [IDx-DR]

• 00860005195619: V2
• 00860005195626: v2.3