Varithena® Administration Pack

GUDID 05060116921328

The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer.

BIOCOMPATIBLES UK LTD

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• Primary Device ID: 05060116921328
• NIH Device Record Key: 6103b42c-a252-4afb-a917-bc5bf967bc9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varithena® Administration Pack
• Version Model Number: FP00024
• Company DUNS: 222870839
• Company Name: BIOCOMPATIBLES UK LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com
• Phone: 855 971 8346
• Email: medical.services@btgplc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060116921328 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Varithena® Administration Pack]

• 05060116921175: The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Si
• 05060116921328: The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Si