Nio Color 2MP K9300331B

GUDID 05415334002609

MDNC-2123 DE WP MKII

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334002609
NIH Device Record Key3d3aa3c1-5654-44b9-a1a4-81334b36e6e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNio Color 2MP
Version Model NumberMDNC-2123
Catalog NumberK9300331B
Company DUNS371618773
Company NameBarco NV
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334002609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGYDisplay, diagnostic radiology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-06
Device Publish Date2019-04-26

On-Brand Devices [Nio Color 2MP]

05415334002029MDNC-2123 DE WP
05415334002005MDNC-2221 EM
05415334000384MDNC-2123 DE WH
05415334000377MDNC-2123 EM BL
05415334002623MDNC-2123 NEU MKII
05415334002616MDNC-2123 EM BL MKII
05415334002609MDNC-2123 DE WP MKII
05415334002357MDNC-2123 DE WH MKII
05415334032880MDNC-2521 SPES
05415334032873MDNC-2521 SNES
05415334043916MDNC-2123 DE WH
05415334043763MDNC-2521 SNES
05415334043749MDNC-2521 SPES

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