FDA.reportPublic FDA data

Perfusion Coupler

Primary DI
13700911901055
Brand
Perfusion Coupler
Company
INSTITUT GEORGES LOPEZ
Model
PCO25
Device description
The Perfusion Coupler shall be used only with the DCX Organ Cassette or the DCM Organ Cassette.This accessory is supplied sterile, disposable and is a single-use device.The Perfusion Coupler has a 25cm length.
Published
2025-05-26
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

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
K243998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243998000DCX Disposable Cassette (DCX)Institut Geroges Lopez2025-04-25KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23700911901052PackageGS125In Commercial Distribution
33700911901059PackageGS1400In Commercial Distribution
13700911901055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2370091190105223700911901052
3370091190105933700911901059
1370091190105513700911901055

GMDN Terms#

Term, Definition table
TermDefinition
Kidney donor-organ preservation/transport perfusion setA collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
393146183
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700911901000Perfusion CannulaPCAN32026-05-11
13700911901017Perfusion CannulaPCAN52026-05-11
13700911901024Perfusion CannulaPCAN82026-05-11
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
13700911900638Perfusion ClampPC10252023-06-05

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
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
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