X°Port Lung Preservation Solution

FDA UDI

Class II (US FDA UDI)

by Traferox Technologies, Inc.

Identity

Trade Name: X°Port Lung Preservation Solution FDA UDI
Generic Name: Donor-organ/tissue/cell preservation solution FDA UDI
Device Name: The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. FDA UDI
Model / Reference: 910-0003-1L FDA UDI
Description: The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. FDA UDI

Identifiers

Primary DI / UDI-DI: 07540161670214 FDA UDI
510(k) Number: K243870 FDA UDI
FDA Product Code: KDN FDA UDI
GMDN Term: Donor-organ/tissue/cell preservation solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Donor-organ/tissue/cell preservation solution

X°Port Lung Preservation Solution by Traferox Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K243870 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Traferox Technologies, Inc.

Sources (1)

FDA UDI 9b6d95f6-a3e0-478e-98dd-720758dddfa6 34 fields · synced Jun 8, 2026