FDA.reportPublic FDA data

PERF-GEN Pulsatile Perfusion Solution

Primary DI
23700911900499
Brand
PERF-GEN Pulsatile Perfusion Solution
Company
INSTITUT GEORGES LOPEZ
Model
PERF-GEN/1000/US
Device description
Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Published
2022-07-27
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
KDLSet, Perfusion, Kidney, Disposable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221386000PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez2022-06-14KDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23700911900499PackageGS110In Commercial Distribution
13700911900492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2370091190049923700911900499
1370091190049213700911900492

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
Storage Environment Temperature35.6 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
393146183
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
13700911901000Perfusion CannulaPCAN32026-05-11
13700911901017Perfusion CannulaPCAN52026-05-11
13700911901024Perfusion CannulaPCAN82026-05-11
13700911901055Perfusion CouplerPCO252025-05-26
13700911900577DCX Disposable CassetteDCX2025-05-26
23700911901052Perfusion CouplerPCO252025-05-26
13700911900928Perfusion Clamp with AdaptorPC1020A2024-10-18
13700911900935Perfusion Clamp with AdaptorPC715A2024-10-18
13700911900942Perfusion Clamp with AdaptorPC1025A2024-10-18
23700911900925Perfusion Clamp with AdaptorPC1020A2024-10-18
23700911900932Perfusion Clamp with AdaptorPC715A2024-10-18
23700911900949Perfusion Clamp with AdaptorPC1025A2024-10-18
13700911900652PARAGON-W (UW solution)PRGNX/100052023-12-22
13700911900669PARAGON-W (UW solution)PRGNX/100062023-12-22
23700911900659PARAGON-W (UW solution)PRGNX/100052023-12-22
23700911900666PARAGON-W (UW solution)PRGNX/100062023-12-22
13700911900522BEL-GEN Cold Storage SolutionBEL-GEN/2000/US2022-07-21
13700911900591Waters IGL Cold Storage SolutionCSS/10002023-05-24
13700911900607Waters IGL Cold Storage SolutionCSS/20002023-05-24
13700911900621Perfusion ClampPC10202023-06-05

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
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
00815045020308SPS-1® (UW Solution)ORGAN RECOVERY SYSTEMS, INC.KDL2017-10-16