Chronicle Web

GUDID 00860007318726

Qr8 Health Inc

Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software

Primary Device ID	00860007318726
NIH Device Record Key	927d803f-b6c7-4661-adc5-06d276f5f285
Commercial Distribution Status	In Commercial Distribution
Brand Name	Chronicle Web
Version Model Number	CHR-COG-W10
Company DUNS	080506730
Company Name	Qr8 Health Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	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
GS1	00860007318726 [Primary]

FDA Product Code

PTY	Computerized Cognitive Assessment Aid, Exempt

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	2022-02-21
Device Publish Date	2022-02-11

Devices Manufactured by Qr8 Health Inc

00860007318788 - Chronicle Web v2.0	2024-05-28
00860007318795 - Cognition Chronicle v2.0	2024-05-28
00860011850922 - Cognition Snapshot+ v2.4	2024-05-07
00860011850908 - MSPT v3.1.1	2024-04-15
00860011850915 - MSPT Web v3.1.0	2024-04-15
00195893329458 - MSPT Web v3.0	2024-03-11
00195893702190 - MSPT v3.0	2024-02-26
00860007318771 - Cognition Snapshot+ 2.3.0	2023-11-09