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
00851074007057VX3+ - Holter Recorder651-636-9770udi@intricon.com
00851074007088Sirona - Generic Sirona Kit651-636-9770udi@intricon.com
00851074007095VX3+ - Holter Recorder651-636-9770udi@intricon.com
00851074007101Sirona - Smart Dock651-636-9770udi@intricon.com
00851074007118Performer + - ECG Recorder651-636-9770udi@intricon.com
00851074007125Sirona - Sirona B PC App651-636-9770udi@intricon.com
00851074007132Sirona - Sirona B iOS App651-636-9770udi@intricon.com
00851074007149Sirona - Sirona B Android App651-636-9770udi@intricon.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#