FDA.reportPublic FDA data

SPS-1® (UW Solution)

Primary DI
00815045020308
Brand
SPS-1® (UW Solution)
Company
ORGAN RECOVERY SYSTEMS, INC.
Model
SPS-1
Device description
SPS-1® (UW Solution), Static Preservation Solution (1 Liter)
Published
2017-10-16
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091656000SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc.2010-03-11KDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815045020305PackageGS110In Commercial Distribution
00815045020308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081504502030510815045020305
00815045020308008150450203088150450203080815045020308

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ/tissue/cell preservation solutionA solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
078972580
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
10815045020213LifePort® 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