Merge Hemo

GUDID 00842000100874

MERGE HEALTHCARE SOLUTIONS INC.

Patient monitoring system module, multifunction
Primary Device ID00842000100874
NIH Device Record Key46e6d019-b47d-4e7a-ab38-4aecaba711fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge Hemo
Version Model Number10.3
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842000100874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-01
Device Publish Date2020-04-23

On-Brand Devices [Merge Hemo ]

0084200010003410.1
0084200010001010.0.4
0084200010043010.2
0084200010087410.3
0084200010096610.4
0084200010044711.0
008420001000279.4
00842000101079RCSV2

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