Paragonix SherpaPak Cardiac Transport System

GUDID 10850005470271

SherapaPak SherpaCool Ribbons and Pouch

PARAGONIX TECHNOLOGIES INC

General-purpose donor-organ preservation/transport system

• Primary Device ID: 10850005470271
• NIH Device Record Key: ce742fa3-33ca-46f8-96cd-c63050282893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragonix SherpaPak Cardiac Transport System
• Version Model Number: SHRP-1001-002
• 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: 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	10850005470271 [Primary]
GS1	20850005470278 [Package]; Package: Outer Box [1 Units]; In Commercial Distribution

FDA Product Code

• MSB: System And Accessories, Isolated Heart, Transport And Preservation

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: 2019-02-15

On-Brand Devices [Paragonix SherpaPak Cardiac Transport System]

• 00869582000385: Paragonix SherpaPak Cardiac Transport System HC 32mm
• 00869582000378: Paragonix SherpaPak Cardiac Transport System HC 25.4mm
• 00869582000361: Paragonix SherpaPak Cardiac Transport System HC 18mm
• 00869582000354: Paragonix SherpaPak Cardiac Transport System HC 10mm
• 00869582000347: Paragonix SherpaPak Cardiac Transport System Ships with 4 heart connectors: 00869582000354 (10mm
• 00869582000330: Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 0
• 00869582000323: Paragonix SherpaCool Ribbons and Pouch
• 10869582000313: Paragonix SherpaPak Shipper CTS
• 10850005470271: SherapaPak SherpaCool Ribbons and Pouch