Nio 5MP LED K9300351C

GUDID 05415334030312

MDNG-5221 BB MKIII

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334030312
• NIH Device Record Key: e87acea7-6f99-4d53-8a53-e59e9f801a34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio 5MP LED
• Version Model Number: MDNG-5221
• Catalog Number: K9300351C
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334030312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133984

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: 2021-12-22
• Device Publish Date: 2021-12-14

On-Brand Devices [Nio 5MP LED]

• 05415334000117: MDNG-5221 BB
• 05415334000100: MDNG-5221 BB
• 05415334000094: MDNG-5221 CB
• 05415334000087: MDNG-5221 CB
• 05415334030411: MDNG-5221 CB MKIII
• 05415334030312: MDNG-5221 BB MKIII