PancreasPak

GUDID 10850005470059

PancreasPak Canister (Pouch)

Paragonix Technologies Inc

General-purpose donor-organ preservation/transport system

• Primary Device ID: 10850005470059
• NIH Device Record Key: 4e963f71-e6b4-4083-ac1a-6e610bc54c70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PancreasPak
• Version Model Number: SHRP-3003
• 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
• Phone: 1.781.428.4828
• Email: support@paragonixtechnologies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005470052 [Primary]
GS1	10850005470059 [Package]; Contains: 00850005470052; 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: 2024-09-09
• Device Publish Date: 2024-09-01

On-Brand Devices [PancreasPak]

• 10850005470059: PancreasPak Canister (Pouch)
• 00850005470618: PancreasPak SherpaCool
• 10850005470035: PancreasPak Shipper Base