Coronis 5MP K9301542A

GUDID 05415334000216

MDCG-5221 BB GE

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334000216
NIH Device Record Keyab8a4ca6-5dc8-4ab9-a940-14011ec7d77b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoronis 5MP
Version Model NumberMDCG-5221
Catalog NumberK9301542A
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
GS105415334000216 [Primary]

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 Number3
Public Version Date2018-12-20
Device Publish Date2016-06-30

On-Brand Devices [Coronis 5MP]

05415334001558MDCG-5121
05415334000223MDCG-5221 BB GE
05415334000216MDCG-5221 BB GE
05415334000209MDCG-5221 BB
05415334000193MDCG-5221 BB
05415334000186MDCG-5221 CB
05415334000179MDCG-5221 CB

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