FDA UDI In Commercial Distribution 🇺🇸 United States

Sunquest VUE

DI: B236VUE202210 · Model: 2022.1 · CliniSys, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sunquest VUE
Primary DI
B236VUE202210
Version / Model
2022.1
Company Name
CliniSys, Inc
Labeler DUNS
052934841
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-19
Public Version
1
Public Version Date
2022-12-27
Public Version Status
New
Public Device Record Key
444e1506-1fa8-4e30-9367-c5b89b610a28

Device Description

The intended use of Sunquest VUE is to support laboratories in the management of patient reports and to transfer, store, and display test results and information.

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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NVV Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

GMDN Terms

Code Name
44103 Pathology information system application software

Identifiers

Type ID
Primary B236VUE202210