FDA.reportPublic FDA data

DEFIBTECH, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035217803003521780DEFIBTECH, LLC1N2026-01-01741 BOSTON POST ROAD,SUITE 201 GUILFORD CT US 06437
30129725163012972516Defibtech Branford1N2026-01-0114 Commercial St Branford CT US 06405
30269768733026976873DEFIBTECH LLC1N2026-01-0121 Commerce Dr N Branford CT US 06471

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3159871778325734P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-MKJ2018-02-01
1971691778325734P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-MKJ2018-02-01
204121778325734P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-MKJ2018-02-01
3159871263878661K211289RMU-2000 Automated Chest Compression SystemDRM2021-11-09
1971691263878661K211289RMU-2000 Automated Chest Compression SystemDRM2021-11-09
204121263878661K211289RMU-2000 Automated Chest Compression SystemDRM2021-11-09
3159871761080428K141809RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMDRM2014-10-27
204121761080428K141809RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMDRM2014-10-27
1971691761080428K141809RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMDRM2014-10-27
204121319529267K131525SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2014-04-24
1971691319529267K131525SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2014-04-24
204121508660933K121853DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2012-12-13
1971691508660933K121853DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2012-12-13
1971691271076847K113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2013-01-04
204121271076847K113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2013-01-04
1971691583103391K081259DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2009-06-15
204121583103391K081259DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESMKJ2009-06-15
1971691697642788K033896DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200PMKJ2004-06-16
204121697642788K033896DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200PMKJ2004-06-16
204121486571687K033144DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIESMKJ2003-11-13
1971691486571687K033144DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIESMKJ2003-11-13
1971691757664224K013896SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BAMKJ2002-06-19
204121757664224K013896SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BAMKJ2002-06-19
1971691758182952
204121758182952
1971691172110340

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MKJ172018-02-01
DRM62021-11-09

PMA#

PMN#

GUDID#

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