FDA.reportPublic FDA data

Belzer UW Cold Storage Solution

Primary DI
00199284590434
Brand
Belzer UW Cold Storage Solution
Company
Bridge To Life Ltd.
Model
BUW-006
Device description
For flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 500mL
Published
2025-06-17
Public version status
New
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
KDLSet, Perfusion, Kidney, Disposable
KDNSystem, Perfusion, Kidney

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243384000Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life2025-03-31KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284849280PackageGS16In Commercial Distribution
00199284590434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284849280001992848492801992848492800199284849280
00199284590434001992845904341992845904340199284590434

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(803) 545-0080orders@B2LL.com

Regulatory Flags#

DUNS number
830330457
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199284432970VitaSmart Hypothermic Oxygenated Perfusion System V0001-US2026-02-20
00199284522503VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion KitV0002-US2026-02-20
00198715358155Belzer UW Cold Storage SolutionBUW-0062025-06-17
00199284914773Belzer UW Cold Storage SolutionBUW-0062025-06-17
00199284309944Belzer UW Cold Storage SolutionBUW-0062025-06-17
00199284210417Belzer UW Cold Storage SolutionBUW-0062025-06-17
00860001991208EasiSlushBTLE-12502024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052742105415Servator P Solution with THAM - PVC free bag 1000 ml + vialS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-10-20
08052742105422Servator P Solution with THAM - PVC free bag 3000 ml + vialS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-10-20
00850005470656KidneyVault Portable Renal Perfusion SystemParagonix Technologies IncKDN2026-07-10
00850005470663KidneyVault Portable Renal Perfusion SystemParagonix Technologies IncKDN2026-07-10
00850005470670KidneyVault Portable Renal Perfusion SystemParagonix Technologies IncKDN2026-07-10
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
08052742104432Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104449Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104463Servator M SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDL2026-05-26
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
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13700911901024Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
40331330005006CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330005006CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDL2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
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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
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