AccessGUDID - DEVICE: Sunquest PowerPath (B236PWP12000)

GUDID

Device Identifier (DI) Information

Brand Name: Sunquest PowerPath
Version or Model: 12.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CliniSys, Inc

Primary DI Number: B236PWP12000
Issuing Agency: HIBCC
Commercial Distribution End Date: May 04, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 052934841 *Terms of Use

Device Description: Sunquest PowerPath supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, 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: 6d1dddf3-d139-4baf-ba9d-480c54cf8c10
Public Version Date: July 24, 2023
Public Version Number: 3
DI Record Publish Date: November 12, 2020