No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817655022574 | ELI250c-CAC-ADCAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
2 | 00817655022475 | MDLTYMGR-5BC-XXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
3 | 00817655022468 | MDLTYMGR-5BC-DXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
4 | 00817655022451 | MDLTYMGR-5AE-AXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
5 | 00817655022444 | MDLTYMGR-5AD-AXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
6 | 00817655022437 | MDLTYMGR-5AC-XXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
7 | 00817655022420 | MDLTYMGR-5AC-XXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
8 | 00817655022413 | MDLTYMGR-5AC-XXXXA | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
9 | 00817655022406 | MDLTYMGR-5AC-DXXXX | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
10 | 00817655022390 | MDLTYMGR-5AC-DXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
11 | 00817655022383 | MDLTYMGR-5AC-DXXXA | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
12 | 00817655022376 | MDLTYMGR-5AC-CXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
13 | 00817655022352 | MDLTYMGR-5AC-BXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
14 | 00817655022345 | MDLTYMGR-5AC-BXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
15 | 00817655022338 | MDLTYMGR-5AC-BXXXA | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
16 | 00817655022321 | MDLTYMGR-5AC-AXXXX | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
17 | 00817655022314 | MDLTYMGR-5AC-AXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
18 | 00817655022307 | MDLTYMGR-5AC-AXXXA | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
19 | 00817655022291 | MDLTYMGR-5AA-AXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
20 | 00817655022253 | MDLTYMGR-5AA-AXXXA | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
21 | 00817655022123 | ELI150c-BEA-ACGBD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
22 | 00817655020358 | ELI250c-BAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
23 | 00817655020341 | ELI150c-BAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
24 | 00817655020327 | ELI150c-IAB-AFHAB | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
25 | 00817655021973 | ELI250c-AAC-AAAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
26 | 00817655021935 | QS-6ID-AGDAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
27 | 00817655021881 | QS-6FC-AXDXA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
28 | 00817655021867 | ELI150c-AAA-AACAD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
29 | 00817655021843 | ELI150c-DAA-AAHAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
30 | 00817655021805 | ELI150c-HAA-ADGBD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
31 | 00817655021799 | ELI250c-CAA-ADFBD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
32 | 00817655021768 | ELI150c-CAA-AAHAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
33 | 00817655021751 | ELI150c-GAA-ABCBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
34 | 00817655021645 | ELI250c-EAA-AAAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
35 | 00817655021478 | ELI250c-MAA-ABBAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
36 | 00817655021423 | 41000-030-64 | Cardiopulmonary accessory kit cleared with XScribe | DPS | Electrocardiograph | 2 | XScribe Cardiopulmonary Kit | |
37 | 00817655021416 | ELI250c-CAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
38 | 00817655021409 | ELI250c-AAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
39 | 00817655021393 | ELI150c-CAA-AFHAB | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
40 | 00817655021386 | ELI250c-KAA-ADFAD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
41 | 00817655021355 | QS-6AA-DDCAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
42 | 00817655021331 | QS-6GD-XGDAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
43 | 00817655021324 | ELI250c-MAA-AABAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
44 | 00817655021317 | ELI150c-BAA-AACAD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
45 | 00817655021300 | ELI250c-CAA-AACAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
46 | 00817655021119 | QS-6HD-AXAAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
47 | 00817655023014 | ELI250c-CAA-AACBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
48 | 00817655023007 | ELI150c-AAA-ABAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
49 | 00817655022994 | ELI150c-GEA-ABCBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
50 | 00817655022963 | ELI250c-MAA-ABCBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B635BIOTRES100 | 1.0 | Biotricity | BIOTRICITY INC | ||
2 | B632MDB01023 | HA3P | MDB01023 | Mediblu | MEDIBLU MEDICAL LLC | |
3 | B353MM12501 | MM1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | MonitorMe | LIFESIGNALS, INC. | |
4 | B353MA12511 | MA1251 | MA1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | MAWI | LIFESIGNALS, INC. |
5 | B353LP12531 | LP1253 | LP1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | LifeSignals | LIFESIGNALS, INC. |
6 | B353LP12511 | LP1251 | LP1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | LifeSignals | LIFESIGNALS, INC. |
7 | B353LP12501 | LP1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | LifeSignals | LIFESIGNALS, INC. | |
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. | |
10 | B353CV12531 | CV1253 | CV1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | CorVitals | LIFESIGNALS, INC. |
11 | B353CV12451 | CV1245 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | CORVITALS | LIFESIGNALS, INC. | |
12 | B353AB12571 | AB1257 | AB1257_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | Advance Biometrix | LIFESIGNALS, INC. |
13 | B353AB12511 | AB1251 | AB1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | Advance Biometrix | LIFESIGNALS, INC. |
14 | B329AWVC23 | Cardio | 08-603 | Ambulatory ECG recorder with accelerometer - single channel | Actiwave | CAMNTECH LIMITED |
15 | B329AWV04E22 | 4E | 08-557 | Ambulatory ECG/EEG recorder - four channel | Actiwave | CAMNTECH LIMITED |
16 | B329AWV02M25 | 2M | 08-536 | Ambulatory Electromyogram (EMG) - two channel | Actiwave | CAMNTECH LIMITED |
17 | B329AWV02E25 | 2E | 08-521 | Ambulatory ECG/EEG recorder - two channel | Actiwave | CAMNTECH LIMITED |
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 | |
46 | B146DL8CN0 | 900-0543-15 | Holter Monitor | DL800 CardioNet | BRAEMAR MANUFACTURING, LLC | |
47 | B146DL8CL0 | 900-0543-11 | Holter Recorder | DL800 CardioLabs | BRAEMAR MANUFACTURING, LLC | |
48 | B146DL8BD0 | 900-0543-19 | Holter Recorder | DL800 Biomedical SYS | BRAEMAR MANUFACTURING, LLC | |
49 | B146DL8B1330 | 900-0543-04 | Holter Recorder | DL800 Braemar 133 s/s | BRAEMAR MANUFACTURING, LLC | |
50 | B146DL8256B0 | 900-0543-09 | Holter Recorder | DL800 Braemar 256 s/s 10 bit | BRAEMAR MANUFACTURING, LLC |