Demetra

GUDID 05415334001763

Demetra BDEM-01

Barco NV

Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital Dermatoscope, digital

• Primary Device ID: 05415334001763
• NIH Device Record Key: 179d03ee-70f1-4b18-8269-8aabef98a6e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Demetra
• Version Model Number: Demetra
• 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
• 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	05415334001763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192829

FDA Product Code

• PSN: Light based imaging

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: 2020-06-12
• Device Publish Date: 2020-06-04

On-Brand Devices [Demetra]

• 05415334001763: Demetra BDEM-01
• 05415334036192: non-invasive skin analysis system.