FDA.reportPublic FDA data

LifePort® Kidney Transporter

Primary DI
10815045020336
Brand
LifePort® Kidney Transporter
Company
ORGAN RECOVERY SYSTEMS, INC.
Model
CAN1035
Device description
LifePort® Kidney Transporter Disposable SealRing® Cannula (10x35)
Published
2017-10-16
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
K021362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021362000LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)Organ Recovery Systems, Inc.2003-07-31KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815045020336PackageGS15In Commercial Distribution
00815045020339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081504502033610815045020336
00815045020339008150450203398150450203390815045020339

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078972580
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
true
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
00815045020346KPS-1®KPS-12017-10-16
00815045020605LifePort® Kidney TransporterLKT201X2025-08-14
00815045020230LifePort® Kidney TransporterCAN00052017-10-16
00815045020254LifePort® Kidney TransporterCAN00082017-10-16
00815045020278LifePort® Kidney TransporterCAN07202017-10-16
00815045020285SPS-1® (UW Solution)SPS-12017-10-16
00815045020308SPS-1® (UW Solution)SPS-12017-10-16
00815045020315LifePort® Kidney TransporterCAN10002017-10-16
00815045020322SPS-1® (UW Solution)SPS-12017-10-16
00815045020339LifePort® Kidney TransporterCAN10352017-10-16
00815045020438LifePort® Kidney TransporterUCAN00032017-10-16
00815045020452LifePort® Kidney TransporterUCAN00052017-10-16
00815045020476LifePort® Kidney TransporterUCAN00072017-10-16
00815045020568LifePort® Kidney TransporterUCAN00092017-10-16
00815045020582LifePort® Kidney TransporterLKT200X2025-02-06
00815045020353LifePort® Kidney TransporterLKT2002017-10-16
00815045020377LifePort® Kidney TransporterLKT2012017-10-16
00815045020391LifePort® Kidney TransporterLKT3002017-10-16
00815045020063LifePort® Kidney TransporterLKT3002017-10-16
00815045020216LifePort® Kidney TransporterCAN00032017-10-16

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