BAROguard

Basic Information

• Brand Name: BAROguard
• Primary DI: 00850005470229
• Version / Model: 112
• Catalog Number: PRGNX-7007-002
• Company Name: PARAGONIX TECHNOLOGIES INC
• Labeler DUNS: 961780660
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-09
• Public Version: 1
• Public Version Date: 2023-11-17
• Public Version Status: New
• Public Device Record Key: 67f49fde-c362-4a01-adfe-8290b2487bff

Device Description

BAROguard SherpaCool Inner Box

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDN	System, Perfusion, Kidney	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	00850005470229	GS1

Premarket Submissions

Submission Number	Supplement Number
K223874	000