FDA.reportPublic FDA data

PancreasPak

Primary DI
00850005470618
Brand
PancreasPak
Company
Paragonix Technologies Inc
Model
SHRP-3003-002
Device description
PancreasPak SherpaCool
Published
2024-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00850005470618PackageGS11In Commercial Distribution
00850005470045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005470618008500054706188500054706180850005470618
00850005470045008500054700458500054700450850005470045

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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
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
10850005470059PancreasPakSHRP-30032024-09-01
00850005470199BAROguardPRGNX-7007-003-0032023-11-09
00850005470205BAROguardPRGNX-7007-003-0012023-11-09
00850005470212BAROguardPRGNX-7007-003-0022023-11-09

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