AccessGUDID - DEVICE: PACSgear Enterprise Server (00850677007396)

GUDID

Device Identifier (DI) Information

Brand Name: PACSgear Enterprise Server
Version or Model: 5.1.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HYLAND LLC

Primary DI Number: 00850677007396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079941872 *Terms of Use
Previous DI: 00850677007259

Device Description: PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear

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?
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data 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: 1f6e15da-abb8-4cd8-b390-6ebe478b9582
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: November 13, 2020