Nio 3MP LED K9301862A

GUDID 05415334000353

MDNG-3220 CN

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334000353
• NIH Device Record Key: 8a6c351a-9246-415d-8699-615a8b14f8a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio 3MP LED
• Version Model Number: MDNG-3220
• Catalog Number: K9301862A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334000353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150821

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: 2016-06-30

On-Brand Devices [Nio 3MP LED]

• 05415334000360: MDNG-3220 W/O FF CN
• 05415334000353: MDNG-3220 CN
• 05415334000346: MDNG-3220 W/O FF
• 05415334000339: MDNG-3220