FDA.reportPublic FDA data

SPS-1® (UW Solution)

Primary DI
10815045020329
Brand
SPS-1® (UW Solution)
Company
ORGAN RECOVERY SYSTEMS, INC.
Model
SPS-1
Device description
SPS-1® (UW Solution), Static Preservation Solution (2 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
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
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
10815045020329PackageGS15In Commercial Distribution
00815045020322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081504502032910815045020329
00815045020322008150450203228150450203220815045020322

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 Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 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