DANA™

GUDID 00860011042105

Anthrotronix, Inc.

Cognitive assessment software

• Primary Device ID: 00860011042105
• NIH Device Record Key: 1809be33-292d-40fb-bdd8-0d583788419c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DANA™
• Version Model Number: 1.0
• Company DUNS: 128374548
• Company Name: Anthrotronix, 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	00860011042105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141865

FDA Product Code

• LQD: Recorder, Attention Task Performance

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: 2023-10-17
• Device Publish Date: 2023-10-09