LIVERguard

GUDID 10850005470295

LIVERguard SherpaCool

PARAGONIX TECHNOLOGIES INC

General-purpose donor-organ preservation/transport system

• Primary Device ID: 10850005470295
• NIH Device Record Key: e759c757-8afc-4be9-b11c-90832a860336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIVERguard
• Version Model Number: PRGNX-6006-002
• 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: true
• 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	00850005470298 [Primary]
GS1	10850005470295 [Package]; Contains: 00850005470298; Package: Inner Box [1 Units]; In Commercial Distribution
GS1	20850005470292 [Package]; Package: Outer Box [1 Units]; In Commercial Distribution

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-30
• Device Publish Date: 2022-12-13

On-Brand Devices [LIVERguard]

• 00850005470304: Paragonix LIVERguard Shipper Base
• 10850005470295: LIVERguard SherpaCool
• 20850005470292: LIVERguard SherpaCool