FDA.reportPublic FDA data

Paragonix SherpaPak Cardiac Transport System

Primary DI
00869582000347
Brand
Paragonix SherpaPak Cardiac Transport System
Company
Paragonix Technologies Inc
Model
SHRP-1001
Device description
Paragonix SherpaPak Cardiac Transport System CanisterShips with 4 heart connectors:00869582000354 (10mm x 1)00869582000361 (18mm x 1)00869582000378 (25.4mm x 1)00869582000385 (32mm x 1)
Published
2019-02-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSBSystem And Accessories, Isolated Heart, Transport And Preservation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSBSystem And Accessories, Isolated Heart, Transport And PreservationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869582000309PackageGS11In Commercial Distribution
00869582000347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869582000309008695820003098695820003090869582000309
00869582000347008695820003478695820003470869582000347

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

Contacts#

Phone, Email table
PhoneEmail
1.781.428.4828support@paragonixtechnologies.com

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

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
08052742104401Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104418Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104425Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104456Servator C SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
40331330005006CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
00850005470649SherpaPak Cardiac Transport System (CTS)Paragonix Technologies IncMSB2025-05-05
04033133420007Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2023-07-03
B00958753OCS Lung Donor Flush SetTRANSMEDICS, INC.MSB2023-06-13
B00958755OCS Lung Donor Flush SetTRANSMEDICS, INC.MSB2023-06-13
13700911900126CELSIOR Cold Storage SolutionINSTITUT GEORGES LOPEZMSB2022-02-07
00851983008060Servator HGLOBAL TRANSPLANT SOLUTIONS, INC.MSB2020-04-21
04033133611016Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-08-08
04033133105003Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
04033133250000Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
04033133610002Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
00869582000316Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
10850005470271Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
10869582000313Paragonix SherpaPak Cardiac Transport SystemPARAGONIX TECHNOLOGIES INCMSB2019-02-15
00869582000323Paragonix SherpaPak Cardiac Transport SystemPARAGONIX TECHNOLOGIES INCMSB2019-02-15
00869582000330Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000354Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000361Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000378Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000385Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
B00944670OCS Lung SystemTRANSMEDICS, INC.MSB2018-06-01
40331330610002CustodiolDr. Franz Köhler Chemie GmbHMSB2016-09-22