Nio Color 2MP K9300332B

GUDID 05415334002616

MDNC-2123 EM BL MKII

Barco NV

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334002616
• NIH Device Record Key: 3845ebfc-3344-460b-b35f-7c4bbf09d9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio Color 2MP
• Version Model Number: MDNC-2123
• Catalog Number: K9300332B
• 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	05415334002616 [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