BAROguard PRGNX-7007-001

GUDID 00850005470311

BAROguard Shipper

PARAGONIX TECHNOLOGIES INC

General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system

• Primary Device ID: 00850005470311
• NIH Device Record Key: 2716d001-72b7-421f-a847-9676411396f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAROguard
• Version Model Number: 112
• Catalog Number: PRGNX-7007-001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005470311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223874

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [BAROguard]

• 20850005470315: BAROguard Shipper Outer Box Contains BAROguard Shipper Inner Box (10850005470318)
• 10850005470318: BAROguard Shipper Inner Box: Contains BAROguard Shipper (00850005470311)
• 10850005470233: BAROguard Sterile Components Outer Box Contains: BAROguard Sterile Components Inner Box (0085000
• 10850005470226: BAROguard SherpaCool Outer Box Contains: BAROguard SherpaCool Inner Box (00850005470229)
• 00850005470311: BAROguard Shipper
• 00850005470236: BAROguard Sterile Components - Inner Box Contains: Organ Container Bag Pouch (00850005470205) Tr
• 00850005470229: BAROguard SherpaCool Inner Box
• 00850005470212: BAROguard Sterile Components - Trachea Connector Pouch
• 00850005470205: BAROguard Sterile Components - Organ Container Bag Pouch
• 00850005470199: BAROguard Sterile Components - Zip Tie Gun Pouch