FDA.reportPublic FDA data

DATRIX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20285301000125122Datrix LLC1N2026-01-01382 State Pl Escondido CA US 92029

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
00851074007262HeartcoR - Cardiac Monitor / ECG Recorder760 480-8874tbrewer@datrixmed.com
00851074007293Broomwell - Sirona PC App760 480-8874tbrewer@datrixmed.com
00851074007316Datrix - ECG Recorder760 480-8874tbrewer@datrixmed.com
00851074007323Heart Smart - ECG Recorder760 480-8874tbrewer@datrixmed.com
00851074007330A.C.T. (American Cardiac Telemetry) - ECG Event Recorder760 480-8874tbrewer@datrixmed.com
00851074007347A.C.T. (American Cardiac Telemetry) - ECG Holter Recorder760 480-8874TBREWER@DATRIXMED.COM
00851074007354CardioDiagnostics - ECG Recorder760 480-8874tbrewer@datrixmed.com
00851074007378Zywie - ECG recorder760 480-8874tbrewer@datrixmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2061911397149945K112601INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDERMWJ2011-11-09
2061912026236251K111160INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)DSI2011-08-01
2061911987195391K042022E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDERDXH2004-08-12
2061911009281269K031074DIGITAL AMBULATORY ECG (HOLTER) RECORDERMWJ2003-10-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWJ42011-11-09
DSI22011-08-01
DXH22004-08-12

PMN#

GUDID#