Nio Color 2MP LED K9301648D

GUDID 05415334037533

Diagnostic display MDNC-2221

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334037533
• NIH Device Record Key: 07032571-4085-4c6b-b76e-1c3781c3ed7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio Color 2MP LED
• Version Model Number: MDNC-2221
• Catalog Number: K9301648D
• Company DUNS: 371618773
• Company Name: Barco NV
• Device Count: 1
• DM Exempt: false
• 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: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334037533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133663

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-01-24
• Device Publish Date: 2022-01-14

On-Brand Devices [Nio Color 2MP LED]

• 05415334031609: MDNC-2221 MKIII
• 05415334031593: MDNC-2221 NC MKIII
• 05415334037533: Diagnostic display MDNC-2221
• 05415334037526: Diagnostic display MDN-2221 NC