Other products from "DATRIX LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00851074007330 Sirona RX93030-009 ECG Event Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 A.C.T. (American Cardiac Telemetry)
2 00851074007040 VX3+ Series A Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 CardioHolter
3 00851074007033 VX3+ Series R Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 BodyGuardian
4 00851074007361 VX3+ Series T VX3+ Series T ECG Recorder MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 Datrix
5 00851074007316 VX3+ Series L ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Datrix
6 00851074007262 Sentinel RX93030-005 Cardiac Monitor / ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 HeartcoR
7 00851074007378 Sirona RX93030-011 ECG recorder MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 Zywie
8 00851074007354 Lifesense mini RX93030-006 ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 CardioDiagnostics
9 00851074007194 Sirona RX22773-003 Sirona PC App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Cardiostaff
10 00851074007170 Sirona RX22711-003 Sirona Android App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Cardiostaff
11 00851074007392 TLC 1-Stop Alert RX93030-013 ECG recorder MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 TLC Diagnostics
12 00851074007347 Sirona RX93030-008 ECG Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 A.C.T. (American Cardiac Telemetry)
13 00851074007293 Sirona RX22773-004 Sirona PC App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Broomwell
14 00851074007255 Sirona RX22773-002 Sirona PC App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 AMI
15 00851074007231 Sirona RX22711-002 Sirona Android App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 AMI
16 00851074007200 Sirona RX93030-004 Cardiac Monitor / ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Broomwell
17 00851074007163 RX93030-001 ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 AMI
18 00851074007156 VX3+ Series H Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 VX3+
19 00851074007095 VX3+ Series Hatco Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 VX3+
20 00851074007064 VX3+ Series CDM Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 VX3+
21 00851074007057 VX3+ Series C Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 VX3+
22 00851074007026 VX3+ Series P Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 VX3+
23 00851074007019 VX3+ Series M Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 VX3+
24 00851074007101 RX92864-000 Smart Dock MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Sirona
25 00851074007132 RX22674 Sirona B iOS App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Sirona
26 00851074007125 RX22673 Sirona B PC App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Sirona
27 00851074007149 RX22711 Sirona B Android App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Sirona
28 00851074007088 RX93051-000 Generic Sirona Kit MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Sirona
29 00851074007002 RX93030-000 ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Sirona
30 00851074007385 Sirona RX93030-012 ECG Recorder (Event) MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 CardioLabs
31 00851074007248 Sirona RX22773-001 Sirona PC App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 CardioLabs
32 00851074007224 Sirona RX22711-001 Sirona Android App MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 CardioLabs
33 00851074007187 RX93030-002 ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 CardioLabs
34 00851074007323 Sirona RX93030-007 ECG Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Heart Smart
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8 B353LA1252R1 LA1252R HOLTER CONNECT Relay Application is a software that is installed on a compatible HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor. HOLTER CONNECT LIFESIGNALS, INC.
9 B353LA1252C1 LA1252C HOLTER CONNECT business logic is a software running on cloud platform that provi HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician. HOLTER CONNECT LIFESIGNALS, INC.
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18 B329AWV01E22 1E 08-514 Ambulatory ECG/EEG recorder - single channel Actiwave CAMNTECH LIMITED
19 B146PERP0 900-0553-06 ENHANCED ALGORITHM ECG EVENT RECORDER PER900 Preventice BRAEMAR MANUFACTURING, LLC
20 B146PERB0 900-0553-03 ENHANCED ALGORITHM ECG EVENT RECORDER PER900 Braemar BRAEMAR MANUFACTURING, LLC
21 B146ER9RAF0 900-0557-07 ENHANCED ALGORITHM ECG EVENT RECORDER ER920 Rozinn, AFIB BRAEMAR MANUFACTURING, LLC
22 B146ER9R0 900-0557-06 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& ENHANCED ALGORITHM ECG EVENT RECORDER ER920 Rozinn BRAEMAR MANUFACTURING, LLC
23 B146ER9BAF0 900-0557-03 ENHANCED ALGORITHM ECG EVENT RECORDER ER920 Braemar, AFIB BRAEMAR MANUFACTURING, LLC
24 B146ER9B0 900-0557-01 ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/r ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652# ER920 Braemar BRAEMAR MANUFACTURING, LLC
25 B146DL9ZW0 900-0570-25 DL900 BRAEMAR MANUFACTURING, LLC
26 B146DL9ST0 900-0570-27 Holter Recorder DL900 Standard BRAEMAR MANUFACTURING, LLC
27 B146DL9RA0 900-0570-14 Holter Recorder DL900 Remote Analysis BRAEMAR MANUFACTURING, LLC
28 B146DL9NV0 900-0570-15 Holter Recorder DL900 Norav 7 day CE BRAEMAR MANUFACTURING, LLC
29 B146DL9NE0 900-0570-24 Holter Recorder DL900 Norav Encrypted BRAEMAR MANUFACTURING, LLC
30 B146DL9FM0 900-0570-23 Holter Recorder DL900 Forest Medical BRAEMAR MANUFACTURING, LLC
31 B146DL9BS0 900-0570-26 Holter Recorder DL900 Base BRAEMAR MANUFACTURING, LLC
32 B146DL9BK0 900-0570-19 Holter Recorder DL900 Burdick 4250 BRAEMAR MANUFACTURING, LLC
33 B146DL9BD0 900-0570-20 Holter Recorder DL900 Biomedical SyS BRAEMAR MANUFACTURING, LLC
34 B146DL9B70 900-0570-16 Holter Recorder DL900 Braemar 7day BRAEMAR MANUFACTURING, LLC
35 B146DL9B0 900-0570-10 Holter Recorder DL900 Braemar SD BRAEMAR MANUFACTURING, LLC
36 B146DL9AT0 900-0570-12 Holter Recorder DL900 Amedtec SD BRAEMAR MANUFACTURING, LLC
37 B146DL95030 900-0616-03 DL950 Braemar Standard BRAEMAR MANUFACTURING, LLC
38 B146DL95020 900-0616-02 DL950 Braemar Base BRAEMAR MANUFACTURING, LLC
39 B146DL95010 900-0616-01 DL950 Braemar BRAEMAR MANUFACTURING, LLC
40 B146DL95000 900-0616-00 DL950 Braemar BRAEMAR MANUFACTURING, LLC
41 B146DL9280 900-0570-28 DL900 BRAEMAR MANUFACTURING, LLC
42 B146DL8NVE0 900-0543-21 DL800 Holter recorder DL800 Norav Encrypted BRAEMAR MANUFACTURING, LLC
43 B146DL8NV0 900-0543-20 Holter Recorder DL800 Norav BRAEMAR MANUFACTURING, LLC
44 B146DL8NO2560 900-0543-12 Holter Monitor DL800 Norav 256 s/s 8bit BRAEMAR MANUFACTURING, LLC
45 B146DL8FM0 900-0543-17 Holter Recorder DL800 Forest Medical 256 s/s 8 bit BRAEMAR MANUFACTURING, LLC
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50 B146DL8256B0 900-0543-09 Holter Recorder DL800 Braemar 256 s/s 10 bit BRAEMAR MANUFACTURING, LLC