FDA.reportPublic FDA data

Paul Dias

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30298716373029871637Paul Dias1N2026-01-01269 Mill Rd Chelmsford MA US 01824
30070939513007093951Paul Dias1N2020-04-25269 Mill Road Chelmsford MA US 01824

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3446811010062364P170027TherOx Downstream SystemMWG2019-04-02
3446812065620647P160034Powerheart® AED G3 ProMKJ2018-12-06
3446811964136418P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3MKJ2018-12-07
3446811957404806P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™MKJ2017-12-27
3446811159897664P160015AED Plus and Fully Automatic AED PlusMKJ2017-05-26
3446812027975175P110024RESQCPR SYSTEMPIZ2015-03-06
3446811862192726K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)NZE2025-10-15
3446812031422705K233486731 Series VentilatorCBK2024-12-13
3446811546316486K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemNZE2023-11-03
3446811971619722K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ ConsoleNCX2023-01-13
3446811234244198K221700AutoPulse NXT Resuscitation SystemDRM2023-03-09
3446811250278631K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ ConsoleNCX2022-06-02
3446811300941937K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleNCX2021-12-20
3446811365990501K202375ZOLL Propaq MMWI2021-03-09
3446811085262889K170533Model 330 Multifunction AspiratorBTA2017-04-18
3446811418304706K162832731 Series VentilatorsCBK2017-08-02
3446812053814097K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX2016-03-24
3446811669788767K141139SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETERNCX2014-10-03
3446811649021216K132488ZOLL CODE WRITERDXJ2014-04-03
3446811315998461K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 100DRM2008-03-19
3446811050554359K033401MODIFICATION TO RESQPOD CIRCULATORY ENHANCERBWF2003-11-20
2437481344956356
3446811024192890
3446811606096761
3446811652201122
3446811726977960
3446811947708942

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NCX52023-01-13
MKJ42018-12-07
NZE22025-10-15
CBK22024-12-13
DRM22023-03-09
MWI12021-03-09
BTA12017-04-18
PIZ 12015-03-06
DXJ12014-04-03
BWF12003-11-20