3CP™ Counterbalance

GUDID 05714188301822

Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).

Reapplix ApS

Centrifuge tube counterbalance

• Primary Device ID: 05714188301822
• NIH Device Record Key: 3ee0ca66-47a5-49f4-9cb0-2c4702cd7e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3CP™ Counterbalance
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 4588168066
• Email: info@reapplix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714188301822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170002

FDA Product Code

• PMQ: Peripheral Blood Processing Device For Wound Management

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: 2018-08-20
• Device Publish Date: 2018-07-19

On-Brand Devices [3CP™ Counterbalance]

• 05714188301822: Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).
• 05714188301808: Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).