FDA.reportPublic FDA data

PARAGONIX TECHNOLOGIES, INC.

Matched from indexed company URL: Paragonix Technologies

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30111755553011175555PARAGONIX TECHNOLOGIES, INC.1Y2026-01-01950 Winter Street, North Waltham MA US 02451

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850005470373KidneyVault - KidneyVault Canister1.781.428.4828support@paragonixtechnologies.com
00850005470595KidneyVault - KidneyVault SherpaCool1.781.428.4828support@paragonixtechnologies.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2178641823589963K234060KIDNEYvault Portable Renal Perfusion SystemKDN2024-10-23
2178641933045634K223874BAROguardKDN2023-08-15
2178641761125737K192869SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemKDN2020-01-16
2178642024431391K191440Paragonix SherpaPak Pancreas Transport SystemKDN2019-12-20
2178641293869649K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemMSB2018-03-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDN42024-10-23
MSB12018-03-30

PMN#

GUDID#

44 records. Showing 1-40. Next