PERFADEX Plus (Click US) 19850

GUDID 07350069520289

PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 10 x 1000ml

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: 07350069520289
• NIH Device Record Key: b26955f0-fa28-4104-a467-27702b702269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERFADEX Plus (Click US)
• Version Model Number: 19850
• Catalog Number: 19850
• 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: 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

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 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350069520289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170826

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

Devices Manufactured by Xvivo Perfusion AB

• 07350069520401 - XVIVO Disposable Lung Kit: 2023-10-09 The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used wit
• 07350069520425 - XVIVO Click Adapter: 2021-11-08 Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
• 07350069520500 - XVIVO Lung Cannula Set II™: 2021-10-11 XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorpore
• 07350069520234 - PERFADEX Plus®: 2019-12-12 Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flush
• 07350069520241 - PERFADEX Plus®: 2019-12-12 Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flush
• 07350069520289 - PERFADEX Plus (Click US): 2019-12-12PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 10 x 1000ml
• 07350069520289 - PERFADEX Plus (Click US): 2019-12-12 PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushi
• 07350069520050 - Perfadex with THAM: 2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal
• 07350069520067 - Perfadex with THAM: 2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal