Nio Color 3MP LED K9300341A

GUDID 05415334001107

MDNC-3421 NC

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334001107
• NIH Device Record Key: 6d4d572f-01b0-4112-b330-da6fff2bb9d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio Color 3MP LED
• Version Model Number: MDNC-3421
• Catalog Number: K9300341A
• 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	05415334001107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131295

FDA Product Code

• LLZ: System, image processing, radiological

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: 2016-08-19

On-Brand Devices [Nio Color 3MP LED]

• 05415334001121: MDNC-3421 CN
• 05415334001114: MDNC-3421LE
• 05415334001107: MDNC-3421 NC
• 05415334000070: MDNC-3421
• 05415334000063: MDNC-3321 HLX
• 05415334000049: MDNC-3321 LE
• 05415334000032: MDNC-3321 W/O FF
• 05415334000025: MDNC-3321