Nio Fusion 12MP K9301130A2X

GUDID 05415334044357

MDNC-12130

Barco NV

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• Primary Device ID: 05415334044357
• NIH Device Record Key: b2e8bcfb-e0fe-4376-bd09-6c67744939e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio Fusion 12MP
• Version Model Number: MDNC-12130
• Catalog Number: K9301130A2X
• 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: +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	05415334044357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203106

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: 2023-12-20
• Device Publish Date: 2023-12-12

On-Brand Devices [Nio Fusion 12MP]

• 05415334028425: MDNC-12130 NC
• 05415334044357: MDNC-12130
• 05415334049734: MDNC-12130 H NC