AccessGUDID - DEVICE: Sunquest Atlas (B236ATL2022110)

GUDID

Device Identifier (DI) Information

Brand Name: Sunquest Atlas
Version or Model: 2022.1 MR1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CliniSys, Inc

Primary DI Number: B236ATL2022110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052934841 *Terms of Use

Device Description: Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform. • Sunquest Physician Portal • Sunquest Advanced EMR Connectivity • Sunquest Patient Service Center (PSC) Portal • Sunquest Multi-Lab Networking

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?
44082	Clinical laboratory information system application software	An application software program, routines, and/or algorithms 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 clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQP	Calculator/Data Processing Module, For Clinical Use

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: 91b86219-afa6-417f-bb1e-a75b74fd6bdb
Public Version Date: July 31, 2023
Public Version Number: 1
DI Record Publish Date: July 21, 2023