LUNGguard

GUDID 10850005470189

Paragonix LUNGguard SherpaCool (Inner Box)

PARAGONIX TECHNOLOGIES INC

General-purpose donor-organ preservation/transport system

• Primary Device ID: 10850005470189
• NIH Device Record Key: f6a7246b-a261-4528-ba59-88b150f82439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUNGguard
• Version Model Number: PRGNX-5005-002
• 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: true
• 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	00850005470182 [Primary]
GS1	10850005470189 [Package]; Contains: 00850005470182; Package: Outer Box [1 Units]; In Commercial Distribution

FDA Product Code

• KDN: System, Perfusion, Kidney

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: 2022-12-13

On-Brand Devices [LUNGguard]

• 10850005470189: Paragonix LUNGguard SherpaCool (Inner Box)
• 00850005470144: Paragonix LUNGguard Shipper Base