NIO 5MP K9300268B

GUDID 05415334001473

MDNG-5121 BB MA GE BUC MKII

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334001473
NIH Device Record Key2465e5ca-efb4-406b-b1b4-b92d16573837
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIO 5MP
Version Model NumberMDNG-5121
Catalog NumberK9300268B
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
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
GS105415334001473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-20
Device Publish Date2016-08-19

On-Brand Devices [NIO 5MP]

05415334001480MDNG-6121
05415334001473MDNG-5121 BB MA GE BUC MKII
05415334001466MDNG-5121 MKII
05415334001459MDNG-5121 BB MA MKII

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