Paragonix SherpaPak Cardiac Transport System

Basic Information

• Brand Name: Paragonix SherpaPak Cardiac Transport System
• Primary DI: 00869582000330
• Version / Model: SHRP-1001-003
• Company Name: PARAGONIX TECHNOLOGIES INC
• Labeler DUNS: 961780660
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-15
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 8bdd993e-f26f-4f75-86d0-d05563612671

Device Description

Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSB	System And Accessories, Isolated Heart, Transport And Preservation	Gastroenterology, Urology	876.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16461	General-purpose donor-organ preservation/transport system	A non-dedicated system designed to support and maintain any donated organ (e.g., heart, kidney, liver) during transport from the donor to the receiving hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869582000330	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]