CARA

GUDID B543CAR0

CARA is an innovative software program that uses enhanced digital images to support and identify the early detection of vision loss and more specifica

Diagnos Inc

Multidisciplinary medical image management software

• Primary Device ID: B543CAR0
• NIH Device Record Key: a494cafe-e218-4ae6-bb09-dfd572b78495
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARA
• Version Model Number: Version 4
• Company DUNS: 200584196
• Company Name: Diagnos 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B543CAR0 [Primary]

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-06-04