Perfadex with THAM 19017

GUDID 07350069520050

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: 8x 1000 ml

Xvivo Perfusion AB

Donor-organ preservation solution
Primary Device ID07350069520050
NIH Device Record Key39dbe32c-b8a1-45e6-a361-5b9f7fdf431a
Commercial Distribution Discontinuation2017-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePerfadex with THAM
Version Model Number19017
Catalog Number19017
Company DUNS559895730
Company NameXvivo Perfusion AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com
Phone+13033959171
Emailinfo@xvivoperfusion.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350069520050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-05
Device Publish Date2016-06-13

On-Brand Devices [Perfadex with THAM]

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

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