FDA.reportPublic FDA data

Custodiol

Primary DI
40331330105003
Brand
Custodiol
Company
Dr. Franz Köhler Chemie GmbH
Model
10 x 500 ml
Published
2016-09-22
Public version status
Update
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
KDLSet, Perfusion, Kidney, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDLSet, Perfusion, Kidney, DisposableGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020924000CUSTODIOL HTK SOLUTIONDr. Franz Kohler Chemie GmbH2003-01-06KDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40331330105003PrimaryGS10
04033133000500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4033133010500340331330105003
04033133000500040331330005004033133000500

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 Degrees Fahrenheit59 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316512953
Device count
10
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
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
04033133250000Custodiol(R)2 x 5000 ml2019-05-09
04033133610002Custodiol(R)6 x 1000 ml2019-05-09
40331330050006Custodiol5000 ml2016-09-19
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
08052742104401Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
08052742104418Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
08052742104425Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
08052742104463Servator M SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
40331330005006CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
00198715358155Belzer UW Cold Storage SolutionBridge To Life Ltd.KDL2025-06-17
00199284914773Belzer UW Cold Storage SolutionBridge To Life Ltd.KDL2025-06-17
00199284590434Belzer UW Cold Storage SolutionBridge To Life Ltd.KDL2025-06-17
13700911900652PARAGON-W (UW solution)INSTITUT GEORGES LOPEZKDL2023-12-22
13700911900669PARAGON-W (UW solution)INSTITUT GEORGES LOPEZKDL2023-12-22
04033133420007Custodiol(R)Dr. Franz Köhler Chemie GmbHKDL2023-07-03
13700911900591Waters IGL Cold Storage SolutionINSTITUT GEORGES LOPEZKDL2023-05-24
13700911900607Waters IGL Cold Storage SolutionINSTITUT GEORGES LOPEZKDL2023-05-24
13700911900614Waters IGL Pulsatile Perfusion SolutionINSTITUT GEORGES LOPEZKDL2023-05-24
23700911900611Waters IGL Pulsatile Perfusion SolutionINSTITUT GEORGES LOPEZKDL2023-05-24
13700911900492PERF-GEN Pulsatile Perfusion SolutionINSTITUT GEORGES LOPEZKDL2022-07-27
23700911900499PERF-GEN Pulsatile Perfusion SolutionINSTITUT GEORGES LOPEZKDL2022-07-27
13700911900522BEL-GEN Cold Storage SolutionINSTITUT GEORGES LOPEZKDL2022-07-21
13700911900119BEL-GEN Cold Storage SolutionINSTITUT GEORGES LOPEZKDL2022-01-31
04033133611016Custodiol(R)Dr. Franz Köhler Chemie GmbHKDL2019-08-08
04033133105003Custodiol(R)Dr. Franz Köhler Chemie GmbHKDL2019-05-09
04033133250000Custodiol(R)Dr. Franz Köhler Chemie GmbHKDL2019-05-09
04033133610002Custodiol(R)Dr. Franz Köhler Chemie GmbHKDL2019-05-09
00815045020216LifePort® Kidney TransporterORGAN RECOVERY SYSTEMS, INC.KDL2017-10-16
00815045020230LifePort® Kidney TransporterORGAN RECOVERY SYSTEMS, INC.KDL2017-10-16
00815045020254LifePort® Kidney TransporterORGAN RECOVERY SYSTEMS, INC.KDL2017-10-16
00815045020278LifePort® Kidney TransporterORGAN RECOVERY SYSTEMS, INC.KDL2017-10-16
00815045020285SPS-1® (UW Solution)ORGAN RECOVERY SYSTEMS, INC.KDL2017-10-16