Nio 5MP LED K9300350C

GUDID 05415334030411

MDNG-5221 CB MKIII

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334030411
NIH Device Record Key6cc2e0dd-e1f7-41d5-b6cf-81e965927187
Commercial Distribution StatusIn Commercial Distribution
Brand NameNio 5MP LED
Version Model NumberMDNG-5221
Catalog NumberK9300350C
Company DUNS371618773
Company NameBarco NV
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 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

Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com
Phone866-302-7939
Emailservice.medical.usa@barco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334030411 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-14

On-Brand Devices [Nio 5MP LED]

05415334000117MDNG-5221 BB
05415334000100MDNG-5221 BB
05415334000094MDNG-5221 CB
05415334000087MDNG-5221 CB
05415334030411MDNG-5221 CB MKIII
05415334030312MDNG-5221 BB MKIII

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