EarliPoint

GUDID 00860009993709

The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.

Earlitec Diagnostics, Inc.

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• Primary Device ID: 00860009993709
• NIH Device Record Key: 473c75fd-0e52-4c1e-b98f-499708e06231
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarliPoint
• Version Model Number: EPT001
• Company DUNS: 117950776
• Company Name: Earlitec 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: true
• 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

Customer Support Contacts

• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com
• Phone: 833-504-9937
• Email: info@earlitecdx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009993709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230337

FDA Product Code

• QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid

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: 2023-08-03
• Device Publish Date: 2023-07-26