FDA UDI Not in Commercial Distribution 🇺🇸 United States

INTELLISPACE™ COGNITION

DI: 00884838098244 · Model: 1.1.X · Philips Electronics Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
INTELLISPACE™ COGNITION
Primary DI
00884838098244
Version / Model
1.1.X
Catalog Number
821401000000
Company Name
Philips Electronics Nederland B.V.
Labeler DUNS
404559718
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-30
Public Version
2
Public Version Date
2020-08-06
Public Version Status
Update
Public Device Record Key
58eda8f9-3eb5-4ed9-9f64-03c7d2bac6bc
Distribution End Date
2020-05-27

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PTY Computerized Cognitive Assessment Aid, Exempt

GMDN Terms

Code Name
63185 Cognitive assessment software

Identifiers

Type ID
Primary 00884838098244