Nio Color 2MP K9300331B

GUDID 05415334002609

MDNC-2123 DE WP MKII

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334002609
• NIH Device Record Key: 3d3aa3c1-5654-44b9-a1a4-81334b36e6e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio Color 2MP
• Version Model Number: MDNC-2123
• Catalog Number: K9300331B
• Company DUNS: 371618773
• Company Name: Barco NV
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334002609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171812

FDA Product Code

• PGY: Display, diagnostic radiology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-06
• Device Publish Date: 2019-04-26

On-Brand Devices [Nio Color 2MP]

• 05415334002029: MDNC-2123 DE WP
• 05415334002005: MDNC-2221 EM
• 05415334000384: MDNC-2123 DE WH
• 05415334000377: MDNC-2123 EM BL
• 05415334002623: MDNC-2123 NEU MKII
• 05415334002616: MDNC-2123 EM BL MKII
• 05415334002609: MDNC-2123 DE WP MKII
• 05415334002357: MDNC-2123 DE WH MKII
• 05415334032880: MDNC-2521 SPES
• 05415334032873: MDNC-2521 SNES
• 05415334043916: MDNC-2123 DE WH
• 05415334043763: MDNC-2521 SNES
• 05415334043749: MDNC-2521 SPES