Paragonix SherpaPak Cardiac Transport System

GUDID 10869582000313

Paragonix SherpaPak Shipper CTS

PARAGONIX TECHNOLOGIES INC

General-purpose donor-organ preservation/transport system
Primary Device ID10869582000313
NIH Device Record Key40e2f66a-6bf0-4153-9355-fbe62b977812
Commercial Distribution StatusIn Commercial Distribution
Brand NameParagonix SherpaPak Cardiac Transport System
Version Model NumberSHRP-1001-001
Company DUNS961780660
Company NamePARAGONIX TECHNOLOGIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com
Phone1.781.428.4828
Emailsupport@paragonixtechnologies.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005470267 [Package]
Contains: 20869582000310
Package: Outer Box [1 Units]
In Commercial Distribution
GS100869582000316 [Primary]
GS110869582000313 [Package]
Contains: 00869582000316
Package: Box [1 Units]
In Commercial Distribution
GS120869582000310 [Package]
Contains: 00869582000316
Package: Inner Box [1 Units]
In Commercial Distribution

FDA Product Code

MSBSystem And Accessories, Isolated Heart, Transport And Preservation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-23
Device Publish Date2019-02-15

On-Brand Devices [Paragonix SherpaPak Cardiac Transport System]

00869582000385Paragonix SherpaPak Cardiac Transport System HC 32mm
00869582000378Paragonix SherpaPak Cardiac Transport System HC 25.4mm
00869582000361Paragonix SherpaPak Cardiac Transport System HC 18mm
00869582000354Paragonix SherpaPak Cardiac Transport System HC 10mm
00869582000347Paragonix SherpaPak Cardiac Transport System Ships with 4 heart connectors: 00869582000354 (10mm
00869582000330Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 0
00869582000323Paragonix SherpaCool Ribbons and Pouch
10869582000313Paragonix SherpaPak Shipper CTS
10850005470271SherapaPak SherpaCool Ribbons and Pouch

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