Merge Hemo - Nellcor PB1000 Assembly

GUDID 00842000100546

Merge Hemo 77-00330-00 Nellcor PB1000 Assembly.

MERGE HEALTHCARE SOLUTIONS INC.

Cardiac catheterization laboratory computer
Primary Device ID00842000100546
NIH Device Record Key1fb5382e-4fe0-41d1-a7d2-c310137c7a85
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge Hemo - Nellcor PB1000 Assembly
Version Model Number77-00330-00
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 Numbertrue
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
GS100842000100546 [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 Date2016-12-01

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