FDA.reportPublic FDA data

LIVERguard

Primary DI
00850005470304
Brand
LIVERguard
Company
Paragonix Technologies Inc
Model
PRGNX-6006-001
Device description
Paragonix LIVERguard Shipper Base
Published
2022-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
10850005470301PackageGS11In Commercial Distribution
20850005470308PackageGS11In Commercial Distribution
00850005470304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000547030110850005470301
2085000547030820850005470308
00850005470304008500054703048500054703040850005470304

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose donor-organ preservation/transport systemA non-dedicated system designed to support and maintain any donated organ (e.g., heart, kidney, liver) during transport from the donor to the receiving hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961780660
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005470649SherpaPak Cardiac Transport System (CTS)SHRP-1001-0022025-05-05
00850005470625KidneyVaultPRGNX-8008-0102025-02-25
00850005470632KidneyVaultPRGNX-8008-0102025-02-25
10850005470226BAROguard112PRGNX-7007-0022023-11-09
00850005470571KidneyVaultPRGNX-8008-0102024-11-25
00850005470335KidneyVaultPRGNX-8008-0012024-11-25
00850005470380KidneyVaultPRGNX-8008-0022024-11-25
00850005470359KidneyVaultPRGNX-8008-0012024-11-25
00850005470373KidneyVaultPRGNX-8008-0022024-11-25
00850005470588KidneyVaultPRGNX-8008-0102024-11-25
00850005470595KidneyVaultPRGNX-8008-0032024-11-25
00850005470236BAROguardPRGNX-7007-0032024-09-10
00850005470038PancreasPakSHRP-3003-0012024-09-01
00850005470045PancreasPak SHRP-3003-0022024-09-01
00850005470052PancreasPakSHRP-30032024-09-01
10850005470035PancreasPakSHRP-3003-0012024-09-01
00850005470618PancreasPak SHRP-3003-0022024-09-01
10850005470059PancreasPakSHRP-30032024-09-01
00850005470199BAROguardPRGNX-7007-003-0032023-11-09
00850005470205BAROguardPRGNX-7007-003-0012023-11-09

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