Nio Color 3MP LED K9300341A

GUDID 05415334001107

MDNC-3421 NC

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334001107
NIH Device Record Key6d4d572f-01b0-4112-b330-da6fff2bb9d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNio Color 3MP LED
Version Model NumberMDNC-3421
Catalog NumberK9300341A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334001107 [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 Color 3MP LED]

05415334001121MDNC-3421 CN
05415334001114MDNC-3421LE
05415334001107MDNC-3421 NC
05415334000070MDNC-3421
05415334000063MDNC-3321 HLX
05415334000049MDNC-3321 LE
05415334000032MDNC-3321 W/O FF
05415334000025MDNC-3321

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