Nio Color 3MP K9300345A

GUDID 05415334001695

MDNC-3421 HLX

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334001695
• NIH Device Record Key: ce1965b2-b3f0-4a07-9912-68cddda9e2e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio Color 3MP
• Version Model Number: MDNC-3421
• Catalog Number: K9300345A
• 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
• 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	05415334001695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170476

FDA Product Code

• PGY: Display, diagnostic radiology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-20
• Device Publish Date: 2017-05-05

On-Brand Devices [Nio Color 3MP]

• 05415334001992: MDNC-3421 EM
• 05415334001916: MDNC-3421 DE
• 05415334001695: MDNC-3421 HLX
• 05415334001688: MDNC-3421 DE NC
• 05415334033672: MDNC-3521 SPES DE
• 05415334032859: MDNC-3521 SPES
• 05415334032842: MDNC-3521 SNES
• 05415334028326: MDNC-3421 DE MKII
• 05415334043770: MDNC-3521 SPES
• 05415334043732: MDNC-3521 SPES DE
• 05415334043725: MDNC-3521 SNES
• 05415334050389: MDNC-3521 SNES
• 05415334050372: MDNC-3521 SPES