Merge Hemo

GUDID 00842000100430

MERGE HEALTHCARE SOLUTIONS INC.

Patient monitoring system module, multifunction
Primary Device ID00842000100430
NIH Device Record Key05ea2565-2e76-43e0-8b34-1171cb90b15e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge Hemo
Version Model Number10.2
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
GS100842000100430 [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 Date2019-07-05
Device Publish Date2019-06-27

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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