KidneyVault

GUDID 00850005470595

KidneyVault SherpaCool

Paragonix Technologies Inc

General-purpose donor-organ preservation/transport system

• Primary Device ID: 00850005470595
• NIH Device Record Key: 9e0beae0-5720-4844-b9c5-fd739d5b2eb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KidneyVault
• Version Model Number: PRGNX-8008-003
• Company DUNS: 961780660
• Company Name: Paragonix Technologies Inc
• 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: true
• Manufacturing Date: true
• 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: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005470595 [Primary]

FDA Product Code

• KDN: System, Perfusion, Kidney

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: 2024-12-03
• Device Publish Date: 2024-11-25

On-Brand Devices [KidneyVault]

• 00850005470595: KidneyVault SherpaCool
• 00850005470588: KidneyVault Cannula Multipack )3mm, 5mm, 7mm, 9mm, 7x20mm)
• 00850005470373: KidneyVault Canister
• 00850005470359: KidneyVault Shipper