X°Port Lung Preservation Solution

GUDID 07540161670245

The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation.

Traferox Technologies Inc

Donor-organ/tissue/cell preservation solution
Primary Device ID07540161670245
NIH Device Record Key41f86196-7997-406f-863b-dc7cac1d5ce2
Commercial Distribution StatusIn Commercial Distribution
Brand NameX°Port Lung Preservation Solution
Version Model Number910-0003-2L
Company DUNS204279512
Company NameTraferox Technologies Inc
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540161670221 [Primary]
GS107540161670245 [Package]
Contains: 07540161670221
Package: [5 Units]
In Commercial Distribution

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 Date2025-09-19
Device Publish Date2025-09-11

On-Brand Devices [X°Port Lung Preservation Solution]

07540161670269The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfus
07540161670245The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfus
07540161670238The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfu

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