FDA.reportPublic FDA data

Servator P Solution with THAM - PVC free bag 3000 ml + vial

Primary DI
08052742105422
Brand
Servator P Solution with THAM - PVC free bag 3000 ml + vial
Company
S.A.L.F. SPA LABORATORIO FARMACOLOGICO
Model
SERP30TDM
Published
2026-10-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052742105429PackageGS12In Commercial Distribution
08052742105422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805274210542918052742105429
08052742105422080527421054228052742105422

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature00

Regulatory Flags#

DUNS number
428653778
Device count
1
DM exempt
false
Premarket exempt
true
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
08052742105415Servator P Solution with THAM - PVC free bag 1000 ml + vialSERP10TDMA2026-10-20
08052742104401Servator H SALF SolutionSERVH10DMA2026-05-26
08052742104418Servator H SALF SolutionSERVH20DMA2026-05-26
08052742104425Servator H SALF SolutionSERVH50DMA2026-05-26
08052742104432Servator B SALF SolutionSERVB20DMA2026-05-26
08052742104449Servator B SALF SolutionSERVB10DMA2026-05-26
08052742104456Servator C SALF SolutionSERVC10DMA2026-05-26
08052742104463Servator M SALF SolutionSERVM10DMA2026-05-26
08052742104487Servator P SALF Solution with THAMSERP10PLUS2026-05-26
08052742104494Servator P SALF Solution with THAMSERP30PLUS2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052742105415Servator P Solution with THAM - PVC free bag 1000 ml + vialS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-10-20
00850005470656KidneyVault Portable Renal Perfusion SystemParagonix Technologies IncKDN2026-07-10
00850005470663KidneyVault Portable Renal Perfusion SystemParagonix Technologies IncKDN2026-07-10
00850005470670KidneyVault Portable Renal Perfusion SystemParagonix Technologies IncKDN2026-07-10
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
05906874879092LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
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