Merge Hemo System

GUDID 00842000100256

Merge Hemo System [Masimo PDM + 10.0.3 Patch 1] Virtual UDI.

MERGE HEALTHCARE SOLUTIONS INC.

Cardiac catheterization laboratory computer
Primary Device ID00842000100256
NIH Device Record Keyee12fdf2-6f3d-416b-9049-d006c51d7345
Commercial Distribution Discontinuation2016-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMerge Hemo System
Version Model NumberMasimo PDM + 10.0.3 Patch 1
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100842000100256 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-30

On-Brand Devices [Merge Hemo System]

00842000100270Merge Hemo System [Masimo PDM + 9.40.3 Patch 1] Virtual UDI.
00842000100263Merge Hemo System [Masimo PDM + 9.40.4] Virtual UDI.
00842000100256Merge Hemo System [Masimo PDM + 10.0.3 Patch 1] Virtual UDI.
00842000100249Merge Hemo System [Masimo PDM + 10.0.4] Virtual UDI.
00842000100218Merge Hemo System [Nellcor PDM + 10.0.4] Virtual UDI.
00842000100201Merge Hemo System [Nellcor PDM + 10.0.3 Patch 1]. Virtual UDI.
00842000100195Merge Hemo System [Nellcor PDM + 9.40.4]. Virtual UDI.
00842000100188Merge Hemo System [Nellcor PDM + 9.40.3 Patch 1] Virtual UDI.

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