3C Patch® Device - Extra Component Set

GUDID 05714188505619

This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.

Reapplix ApS

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• Primary Device ID: 05714188505619
• NIH Device Record Key: 9b3bb7b1-e993-4a41-9b45-012b55c0d598
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3C Patch® Device - Extra Component Set
• Version Model Number: 1
• Company DUNS: 312293991
• Company Name: Reapplix ApS
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com
• Phone: +4588168066
• Email: info@reapplix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714188505619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140211

FDA Product Code

• PMQ: Peripheral Blood Processing Device For Wound Management

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-01-09

On-Brand Devices [3C Patch® Device - Extra Component Set]

• 05714188505619: This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.
• 05714188505602: This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.