Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003521780

FEI Number

3003521780

Entity Name

DEFIBTECH, LLC

City/State/Country

GUILFORD, CT, US

Establishment Address

741 BOSTON POST ROAD,SUITE 201, GUILFORD, CT 06437, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

DEFIBTECH, LLC (Owner Number: 9048526)

Owner / Operator Contact Address

741 BOSTON POST ROAD, SUITE 201, Guilford, CT 06437, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P160032

All Registered Proprietary Names

Lifeline ARM ACC System RMU-1000 Automated Chest Compressor (ACC) System Lifeline View Auto DDU-2200 Fully-Automatic AED Lifeline Auto DDU-120 Fully-Automatic AED DBP-2003 4-year non-rechargeable battery pack DDP-2002 Pediatric Defibrillation Pads Lifeline DDU-100 Semi-Automatic AED Lifeline ECG+ DDU-2475 Semi-Automatic AED DDP-2001 Adult Defibrillation Pads Lifeline ECG DDU-2450 Semi-Automatic AED Lifeline View DDU-2300 Semi-Automatic AED DDP-200P Pediatric Defibrillation Pads DDP-100 Adult Defibrillation Pads DBP-1400 5-year non-rechargeable battery pack DBP-2013 4-year non-rechargeable TSO battery Lifeline PRO DDU-2400 Semi-Automatic AED DBP-2800 7-year non-rechargeable battery pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2014-10-30
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-06-27

Official Correspondent

Robert Jamieson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEFIBTECH, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012972516	Defibtech Branford	Branford, CT, US
3026976873	DEFIBTECH LLC	N Branford, CT, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003521780. Last updated year: 2026. Please use registration number 3003521780 when referencing this establishment in official correspondence.