Nio 5.8MP Gray K9300371B

GUDID 05415334028401

MDNG-6221 NC EM

Barco NV

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• Primary Device ID: 05415334028401
• NIH Device Record Key: 24a58953-0093-4f57-bd73-01ca6b1ebb9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nio 5.8MP Gray
• Version Model Number: MDNG-6221
• Catalog Number: K9300371B
• 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
• 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	05415334028401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170476

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: 2022-05-25
• Device Publish Date: 2022-05-17

On-Brand Devices [Nio 5.8MP Gray]

• 05415334036895: MDNG-6221 SPEF
• 05415334036888: MDNG-6221 SNEF
• 05415334028401: MDNG-6221 NC EM
• 05415334044043: MDNG-6221 SNEF
• 05415334044036: MDNG-6221 SPEF