Nio 3MP LED K9301860A

GUDID 05415334000339

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334000339
NIH Device Record Key0631bff1-c2cc-4903-91b9-46aade387673
Commercial Distribution StatusIn Commercial Distribution
Brand NameNio 3MP LED
Version Model NumberMDNG-3220
Catalog NumberK9301860A
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
GS105415334000339 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-20
Device Publish Date2016-06-30

On-Brand Devices [Nio 3MP LED]

05415334000360MDNG-3220 W/O FF CN
05415334000353MDNG-3220 CN
05415334000346MDNG-3220 W/O FF
05415334000339MDNG-3220

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