Perfadex with THAM 19018

GUDID 07350069520067

Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size 2 x 2800 ml

Xvivo Perfusion AB

Donor-organ preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution

• Primary Device ID: 07350069520067
• NIH Device Record Key: 7ec69c5b-9709-46af-a6f9-c34434d8f6b6
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Perfadex with THAM
• Version Model Number: 19018
• Catalog Number: 19018
• Company DUNS: 559895730
• Company Name: Xvivo Perfusion AB
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com
• Phone: +13033959171
• Email: info@xvivoperfusion.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350069520067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091989

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-05
• Device Publish Date: 2016-06-13

On-Brand Devices [Perfadex with THAM]

• 07350069520067: Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation
• 07350069520050: Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation