FDA.reportPublic FDA data

Custodiol(R)

Primary DI
04033133250000
Brand
Custodiol(R)
Company
Dr. Franz Köhler Chemie GmbH
Model
2 x 5000 ml
Published
2019-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDLSet, Perfusion, Kidney, Disposable
KDNSystem, Perfusion, Kidney
MSBSystem And Accessories, Isolated Heart, Transport And Preservation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDLSet, Perfusion, Kidney, DisposableGastroenterology, Urology2
KDNSystem, Perfusion, KidneyGastroenterology, Urology2
MSBSystem And Accessories, Isolated Heart, Transport And PreservationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020924000
K032794000
K043461000
K992209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020924000CUSTODIOL HTK SOLUTIONDr. Franz Kohler Chemie GmbH2003-01-06KDL
K032794000CUSTODIOLDr. Franz Kohler Chemie GmbH2004-04-05MSB
K043461000CUSTODIOLDr. Franz Kohler Chemie GmbH2005-02-28KDL
K992209000CUSTODIOLDr. Franz Kohler Chemie GmbH1999-12-10KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04033133250000PrimaryGS10
04033133050006Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04033133250000040331332500004033133250000
04033133050006040331330500064033133050006

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ preservation solutionA sterile solution intended to be used in conjunction with a donor-organ preservation/transport set for the flushing, transport, storage and preservation of donor organs (e.g., kidney, liver, heart, and pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain organ viability until the organ can be implanted in the recipient; the solution may be combined with blood. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from light
Storage Environment Temperature35.6 Degrees Fahrenheit46.4 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316512953
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40331330005006Custodiol500 ml2025-09-19
40331330010000Custodiol1000 ml2025-09-19
40331330020009Custodiol2000 ml2025-09-19
04033133020009Custodiol(R)4 x 2000 ml2023-07-03
04033133420007Custodiol(R)4 x 2000 ml2023-07-03
04033133611016Custodiol(R)6 x 1000 ml2019-08-08
04033133105003Custodiol(R)10 x 500 ml2019-05-09
04033133610002Custodiol(R)6 x 1000 ml2019-05-09
40331330050006Custodiol5000 ml2016-09-19
40331330105003Custodiol10 x 500 ml2016-09-22
40331330250000Custodiol2 x 5000 ml2016-09-19
40331330420007Custodiol4 x 2000 ml2016-09-22
40331330610002Custodiol6 x 1000 ml2016-09-22

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
08052742105422Servator P Solution with THAM - PVC free bag 3000 ml + vialS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-10-20
07540161670177X°Port Heart Preservation SystemTraferox Technologies IncMSB2026-09-25
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
08052742104401Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
08052742104401Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104418Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104418Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
08052742104425Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
08052742104425Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104432Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104449Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104456Servator C SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104463Servator M SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
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 GmbHKDL2025-09-19
40331330005006CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330005006CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19