X°Port Lung Preservation System

GUDID 07540161670153

Lung Preservation System

Traferox Technologies Inc

General-purpose donor-organ preservation/transport system

• Primary Device ID: 07540161670153
• NIH Device Record Key: e8015ee3-fdf4-415e-891f-e9f4736229c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X°Port Lung Preservation System
• Version Model Number: 909-0011
• Company DUNS: 204279512
• Company Name: Traferox Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	07540161670153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243870

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: 2025-06-03
• Device Publish Date: 2025-05-26