AccessGUDID - DEVICE: EarliPoint (00860009993709)

GUDID

Device Identifier (DI) Information

Brand Name: EarliPoint
Version or Model: EPT001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Earlitec Diagnostics, Inc.

Primary DI Number: 00860009993709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117950776 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65894	Neurodevelopmental disorder interpretive software	An interpretive, machine-learning-enabled software as a medical device (SaMD) application intended to be used to aid a healthcare professional in the diagnosis of a neurodevelopmental disorder (e.g., autism). It analyses patient demographics and questionnaire data from one or more sources (e.g., parent/caregiver, healthcare professionals) and provides an assessment. It is designed to be installed on an off-the-shelf device and intended primarily for use by a healthcare professional, however includes a parent/caregiver facing application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QPF	Pediatric Autism Spectrum Disorder Diagnosis Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230337	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 473c75fd-0e52-4c1e-b98f-499708e06231
Public Version Date: August 03, 2023
Public Version Number: 1
DI Record Publish Date: July 26, 2023