AccessGUDID - DEVICE: Sunquest VUE (B236VUE202210)

GUDID

Device Identifier (DI) Information

Brand Name: Sunquest VUE
Version or Model: 2022.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CliniSys, Inc

Primary DI Number: B236VUE202210
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052934841 *Terms of Use

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

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?
44103	Pathology information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. It is typically supplied for installation into a dedicated pathology information system or existing mainframe or decentralized computers/networks.	Active	false

FDA Product Code

[?]

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

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: 444e1506-1fa8-4e30-9367-c5b89b610a28
Public Version Date: December 27, 2022
Public Version Number: 1
DI Record Publish Date: December 19, 2022