KidneyVault

GUDID 00850005470588

KidneyVault Cannula Multipack )3mm, 5mm, 7mm, 9mm, 7x20mm)

Paragonix Technologies Inc

General-purpose donor-organ preservation/transport system

• Primary Device ID: 00850005470588
• NIH Device Record Key: a3b0a632-df18-411b-acc8-bd5f90afed79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KidneyVault
• Version Model Number: PRGNX-8008-010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005470571 [Primary]
GS1	00850005470588 [Package]; Contains: 00850005470571; Package: Outer Box [1 Units]; In Commercial Distribution

FDA Product Code

• KDN: System, Perfusion, Kidney

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: 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