PERFADEX Plus® 19900

GUDID 07350069520241

Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended 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: 2 x 3000ml

Xvivo Perfusion AB

Donor-organ preservation solution
Primary Device ID07350069520241
NIH Device Record Key02823746-045b-4057-a9c6-bbba672064a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERFADEX Plus®
Version Model Number19900
Catalog Number19900
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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
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
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 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350069520241 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-12
Device Publish Date2019-12-04

On-Brand Devices [PERFADEX Plus®]

07350069520241Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The
07350069520234Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The

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