Merge Unity PACS

GUDID 00842000100744

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation
Primary Device ID00842000100744
NIH Device Record Keyd6faf458-3d2e-4e6d-b8b1-f8cc537a18f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge Unity PACS
Version Model Number12.0
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842000100744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-09
Device Publish Date2019-03-15

On-Brand Devices [Merge Unity PACS ]

0084200010074412.0
00842000100331Standalone software application
00842000100058Standalone software application
0084200010046111.0
0084200010082913.0

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