AccessGUDID - DEVICE: INTELLISPACE™ COGNITION (00884838103900)

GUDID

Device Identifier (DI) Information

Brand Name: INTELLISPACE™ COGNITION
Version or Model: 4.0.x.x
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 821401000000
Company Name: Philips Electronics Nederland B.V.

Primary DI Number: 00884838103900
Issuing Agency: GS1
Commercial Distribution End Date: June 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 404559718 *Terms of Use

Device Description: Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.

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):	No
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?
63185	Cognitive assessment software	A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.	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: 6633e570-2614-4557-bd98-ea442eb6f0ff
Public Version Date: June 02, 2021
Public Version Number: 3
DI Record Publish Date: January 28, 2021