FDA.reportPublic FDA data

Belzer UW Cold Storage Solution

Primary DI
00810805000026
Brand
Belzer UW Cold Storage Solution
Company
PRESERVATION SOLUTIONS INC
Model
BUW-500
Device description
Formulated for flushing and cold storage of kidney, liver and pancreas organs. 500 mL
Published
2016-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDNSystem, Perfusion, Kidney

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDNSystem, Perfusion, KidneyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810805000023PackageGS16In Commercial Distribution
00810805000026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081080500002310810805000023
00810805000026008108050000268108050000260810805000026

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

Contacts#

Phone, Email table
PhoneEmail
2627236715brader@preservationsolutions.com

Regulatory Flags#

DUNS number
090266979
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810805000139ClearIt Anti-Fog ClothPS0012016-10-22
10810805000146ClearIt Anti-Fog Kit PS0032016-10-11
00810805000040Belzer UW Cold Storage Solution BUW-0012016-10-07
00810805000071Belzer UW Cold Storage SolutionBUW-0022016-10-22
00810805000095Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
00810805000101Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
00810805000156Waters IGL Cold Storage SolutionCSS/1000/US2016-10-22
00810805000163Waters IGL Cold Storage SolutionCSS/2000/US2016-10-22
00810805000170Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
10810805000214"Retention Guard Suture Retention Plates - 3"""RG-32018-12-07
00810805000224"StarGuard Suture Retention Plates - 7"""SG-72018-12-07
00810805000231"StarGuard Suture Retention Plates - 9"""SG-92018-12-07
10810805000092Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
10810805000108Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
10810805000177Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
00810805000187Wittmann PatchEWP20402016-10-22
00810805000194XTACXTAC2016-10-22
10810805000023Belzer UW Cold Storage Solution BUW-5002016-10-22
10810805000047Belzer UW Cold Storage Solution BUW-0012016-10-07
10810805000078Belzer UW Cold Storage SolutionBUW-0022016-10-22

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
13700911901055Perfusion CouplerINSTITUT GEORGES LOPEZKDN2025-05-26
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