FDA.reportPublic FDA data

LungProtect®

Primary DI
05906874879092
Brand
LungProtect®
Company
CARNAMEDICA SP Z O O
Model
2000 ML
Catalog number
LPRT2000
Device description
Container filled with solution for perfusion or preservation of organs intended for transplantation.
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K240650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240650000LungProtectTraferox Technologies, Inc.2024-11-26KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05906874879191PackageGS15In Commercial Distribution
05906874879092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05906874879191059068748791915906874879191
05906874879092059068748790925906874879092

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.

Contacts#

Phone, Email table
PhoneEmail
+48608336159quality@carnamedica.com

Regulatory Flags#

DUNS number
421850941
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05906874879085LungProtect®1000 MLLPRT2025-07-30
05906874879191LungProtect®2000 MLLPRT20002025-07-30

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
13700911901000Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
13700911901017Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
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
07540161670238X°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
05906874879085LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
05906874879191LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
00198715358155Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284914773Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284309944Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284590434Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284210417Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
13700911901055Perfusion CouplerINSTITUT GEORGES LOPEZKDN2025-05-26
07540161670153X°Port Lung Preservation SystemTraferox Technologies IncKDN2025-05-26
13700911900577DCX Disposable CassetteINSTITUT GEORGES LOPEZKDN2025-05-26
23700911901052Perfusion CouplerINSTITUT GEORGES LOPEZKDN2025-05-26
00850005470625KidneyVaultParagonix Technologies IncKDN2025-02-25
00850005470632KidneyVaultParagonix Technologies IncKDN2025-02-25
00850005470335KidneyVaultParagonix Technologies IncKDN2024-11-25