AccessGUDID - DEVICE: DCTclock (B626100390)

GUDID

Device Identifier (DI) Information

Brand Name: DCTclock
Version or Model: 10039
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10039
Company Name: Linus Health, Inc.

Primary DI Number: B626100390
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117137874 *Terms of Use

Device Description: DCTclock Practice Test Form - Research

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:	Yes
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?
30894	Drawing-test cognitive function analysis device	A device designed for professional assessment of a patient’s cognitive function by means of software-based analysis and interpretation of a drawing test (e.g., clock drawing test) performed by the patient. It consists of an electronic digital input device (e.g., pen with a built-in camera), and software; the results are typically combined with patient demographics to provide a summary report.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTY	Computerized Cognitive Assessment Aid, Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 9bdfafa2-6bbd-4ded-9d90-d51c3764df0b
Public Version Date: August 06, 2020
Public Version Number: 3
DI Record Publish Date: February 16, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B626100391	10	B626100390		In Commercial Distribution	shrink wrap

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 617-431-1777
Email: support@digitalcogtech.com

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