X°Port Lung Preservation Solution

Primary DI
07540161670238
Brand
X°Port Lung Preservation Solution
Company
Traferox Technologies Inc
Model
910-0003-1L
Device description
The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation.
Published
2025-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDNSystem, Perfusion, Kidney

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDNSystem, Perfusion, KidneyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243870000X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.2025-05-01KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540161670238PackageGS110In Commercial Distribution
07540161670214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540161670238075401616702387540161670238
07540161670214075401616702147540161670214

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ/tissue/cell preservation solutionA solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204279512
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540161670214X°Port Lung Preservation Solution910-0003-1L2025-09-11
07540161670221X°Port Lung Preservation Solution910-0003-2L2025-09-11
07540161670245X°Port Lung Preservation Solution910-0003-2L2025-09-11
07540161670269X°Port Lung Preservation Solution910-0003-8L-PKG2025-09-11
07540161670153X°Port Lung Preservation System909-00112025-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052742104432Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104449Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104487Servator P SALF Solution with THAMS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104494Servator P SALF Solution with THAMS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
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13700911901024Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
40331330005006CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
07540161670214X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670221X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670245X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670269X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
00815045020605LifePort® Kidney TransporterORGAN RECOVERY SYSTEMS, INC.KDN2025-08-14
05906874879092LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
05906874879085LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
05906874879191LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
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00199284914773Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
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07540161670153X°Port Lung Preservation SystemTraferox Technologies IncKDN2025-05-26
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23700911901052Perfusion CouplerINSTITUT GEORGES LOPEZKDN2025-05-26
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