No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08031527014487 | 2.42UG1 | NVZ | Pulse generator, permanent, implantable | 3 | Smartview | ||
2 | 08031527013909 | 4,5m | NVZ | Pulse generator, permanent, implantable | 3 | ECG Cable | ||
3 | 08031527013435 | V3.10 | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNECOM | ||
4 | 08031527016023 | 7 leads | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
5 | 08031527014210 | None | NVZ | Pulse generator, permanent, implantable | 3 | ORCHESTRA PLUS LINK | ||
6 | 08031527015132 | SPIDERVIEW | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | CUSTODIA | ||
7 | 08031527012247 | SR | NVZ | Pulse generator, permanent, implantable | 3 | Reply | ||
8 | 08031527011523 | DR | NVZ | Pulse generator, permanent, implantable | 3 | Reply | ||
9 | 08031527017877 | KC961 | KC961 | MicroPort SmartView monitor V2+ | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | SmartView monitor |
10 | 08031527014296 | V3.10 USB COM | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | EASYSCOPE | ||
11 | 08031527015149 | Pouch | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
12 | 08031527015095 | 3 Leads XYZ / 7E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
13 | 08031527015088 | 2 Leads / 5 E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
14 | 08031527015071 | 12 Leads / 10 E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
15 | 08031527015064 | XYZ-HR / 7E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
16 | 08031527013398 | SPIDERVIEW | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
17 | 08031527009629 | Reply/Esprit | NVZ | Pulse generator, permanent, implantable | 3 | Screwdriver | ||
18 | 08031527009230 | ICD | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Screwdriver | ||
19 | 08031527009162 | SR | NVZ | Pulse generator, permanent, implantable | 3 | Esprit | ||
20 | 08031527009056 | DR | NVZ | Pulse generator, permanent, implantable | 3 | Esprit | ||
21 | 08031527014944 | V3.10 UPG TO USB COM | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | EASYSCOPE | ||
22 | 08031527014913 | V3.10 Network Lic.USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | EASYSCOPE | ||
23 | 08031527014890 | PLUS | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
24 | 08031527014876 | SPIDERVIEW | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
25 | 08031527012810 | CRT-D 174 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | Intensia | ||
26 | 08031527013893 | 3.3 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Remote Monitoring System | ||
27 | 08031527012834 | VR 124 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Intensia | ||
28 | 08031527012827 | DR 154 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Intensia | ||
29 | 08031527017020 | G999 | G999 | MicroPort CRM USB adapter for CPR3H | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | USB adapter for CPR3H |
30 | 08031527014883 | SD Card | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW+ SD MEMORY CARD | ||
31 | 08031527014654 | 3.4 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Remote Monitoring System | ||
32 | 08031527014289 | SYNESCOPE V3.10 USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNESCOPE | ||
33 | 08031527015057 | 2 Leads / 3E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW / SPIDERFLASH | ||
34 | 08031527013350 | CPR3 | NVZ | Pulse generator, permanent, implantable | 3 | CPR3 | ||
35 | 08031527018089 | KC861 | KC861 | MicroPort Smart Spot (IMV2+) / CPR4BR adapter | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | Smart Spot with CPR4BR accessory |
36 | 08031527015040 | UPGRADE TO SYNESCOPE V3.10 USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNESCOPE | ||
37 | 08031527015033 | NETWORK LICENCE V3,10 USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNESCOPE | ||
38 | 08031527013916 | 3m | NVZ | Pulse generator, permanent, implantable | 3 | ECG Cable | ||
39 | 08031527019956 | TAC004C | TAC004C | MicroPort CRM Magnet | DTG | Magnet, Test, Pacemaker | 1 | Magnet |
40 | 08031527013381 | Wireless | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Smartview Monitor | ||
41 | 08031527013374 | Landline | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Smartview Monitor | ||
42 | 08031527012278 | CRT-D 9750 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | Paradym RF | ||
43 | 08031527012261 | VR 9250 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Paradym RF | ||
44 | 08031527012254 | DR 9550 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Paradym RF | ||
45 | 08031527017013 | GB78 | GB78 | MicroPort CRM CPR3H telemetry head for SmartTouch | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | CPR3H |
46 | 08031527015569 | 4LV CRT-D 1744 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | PLATINIUM | ||
47 | 08031527015538 | CRT-D 1711 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | PLATINIUM | ||
48 | 08031527015460 | VR 1240 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | PLATINIUM | ||
49 | 08031527017754 | B10000 | B10000 | MicroPort CPR4BR accessory | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | CPR4BR accessory |
50 | 08031527017334 | K379 | K379 | MicroPort CRM Smart ECG | MRM | Defibrillator, Implantable, Dual-Chamber | 3 | Smart ECG |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B353MM12501 | MM1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | MonitorMe | LIFESIGNALS, INC. | |
2 | B353MA12511 | MA1251 | MA1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | MAWI | LIFESIGNALS, INC. |
3 | B353LP12531 | LP1253 | LP1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | LifeSignals | LIFESIGNALS, INC. |
4 | B353LP12511 | LP1251 | LP1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | LifeSignals | LIFESIGNALS, INC. |
5 | B353LP12501 | LP1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | LifeSignals | LIFESIGNALS, INC. | |
6 | 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. | |
7 | 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. | |
8 | B353CV12531 | CV1253 | CV1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | CorVitals | LIFESIGNALS, INC. |
9 | B353CV12451 | CV1245 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | CORVITALS | LIFESIGNALS, INC. | |
10 | B353AB12571 | AB1257 | AB1257_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | Advance Biometrix | LIFESIGNALS, INC. |
11 | B353AB12511 | AB1251 | AB1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | Advance Biometrix | LIFESIGNALS, INC. |
12 | B329AWVC23 | Cardio | 08-603 | Ambulatory ECG recorder with accelerometer - single channel | Actiwave | CAMNTECH LIMITED |
13 | B329AWV04E22 | 4E | 08-557 | Ambulatory ECG/EEG recorder - four channel | Actiwave | CAMNTECH LIMITED |
14 | B329AWV02M25 | 2M | 08-536 | Ambulatory Electromyogram (EMG) - two channel | Actiwave | CAMNTECH LIMITED |
15 | B329AWV02E25 | 2E | 08-521 | Ambulatory ECG/EEG recorder - two channel | Actiwave | CAMNTECH LIMITED |
16 | B329AWV01E22 | 1E | 08-514 | Ambulatory ECG/EEG recorder - single channel | Actiwave | CAMNTECH LIMITED |
17 | B146PERP0 | 900-0553-06 | ENHANCED ALGORITHM ECG EVENT RECORDER | PER900 Preventice | BRAEMAR MANUFACTURING, LLC | |
18 | B146PERB0 | 900-0553-03 | ENHANCED ALGORITHM ECG EVENT RECORDER | PER900 Braemar | BRAEMAR MANUFACTURING, LLC | |
19 | B146ER9RAF0 | 900-0557-07 | ENHANCED ALGORITHM ECG EVENT RECORDER | ER920 Rozinn, AFIB | BRAEMAR MANUFACTURING, LLC | |
20 | 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 |
21 | B146ER9BAF0 | 900-0557-03 | ENHANCED ALGORITHM ECG EVENT RECORDER | ER920 Braemar, AFIB | BRAEMAR MANUFACTURING, LLC | |
22 | 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 | |
23 | B146DL9ZW0 | 900-0570-25 | DL900 | BRAEMAR MANUFACTURING, LLC | ||
24 | B146DL9ST0 | 900-0570-27 | Holter Recorder | DL900 Standard | BRAEMAR MANUFACTURING, LLC | |
25 | B146DL9RA0 | 900-0570-14 | Holter Recorder | DL900 Remote Analysis | BRAEMAR MANUFACTURING, LLC | |
26 | B146DL9NV0 | 900-0570-15 | Holter Recorder | DL900 Norav 7 day CE | BRAEMAR MANUFACTURING, LLC | |
27 | B146DL9NE0 | 900-0570-24 | Holter Recorder | DL900 Norav Encrypted | BRAEMAR MANUFACTURING, LLC | |
28 | B146DL9FM0 | 900-0570-23 | Holter Recorder | DL900 Forest Medical | BRAEMAR MANUFACTURING, LLC | |
29 | B146DL9BS0 | 900-0570-26 | Holter Recorder | DL900 Base | BRAEMAR MANUFACTURING, LLC | |
30 | B146DL9BK0 | 900-0570-19 | Holter Recorder | DL900 Burdick 4250 | BRAEMAR MANUFACTURING, LLC | |
31 | B146DL9BD0 | 900-0570-20 | Holter Recorder | DL900 Biomedical SyS | BRAEMAR MANUFACTURING, LLC | |
32 | B146DL9B70 | 900-0570-16 | Holter Recorder | DL900 Braemar 7day | BRAEMAR MANUFACTURING, LLC | |
33 | B146DL9B0 | 900-0570-10 | Holter Recorder | DL900 Braemar SD | BRAEMAR MANUFACTURING, LLC | |
34 | B146DL9AT0 | 900-0570-12 | Holter Recorder | DL900 Amedtec SD | BRAEMAR MANUFACTURING, LLC | |
35 | B146DL95030 | 900-0616-03 | DL950 Braemar Standard | BRAEMAR MANUFACTURING, LLC | ||
36 | B146DL95020 | 900-0616-02 | DL950 Braemar Base | BRAEMAR MANUFACTURING, LLC | ||
37 | B146DL95010 | 900-0616-01 | DL950 Braemar | BRAEMAR MANUFACTURING, LLC | ||
38 | B146DL95000 | 900-0616-00 | DL950 Braemar | BRAEMAR MANUFACTURING, LLC | ||
39 | B146DL9280 | 900-0570-28 | DL900 | BRAEMAR MANUFACTURING, LLC | ||
40 | B146DL8NVE0 | 900-0543-21 | DL800 Holter recorder | DL800 Norav Encrypted | BRAEMAR MANUFACTURING, LLC | |
41 | B146DL8NV0 | 900-0543-20 | Holter Recorder | DL800 Norav | BRAEMAR MANUFACTURING, LLC | |
42 | B146DL8NO2560 | 900-0543-12 | Holter Monitor | DL800 Norav 256 s/s 8bit | BRAEMAR MANUFACTURING, LLC | |
43 | B146DL8FM0 | 900-0543-17 | Holter Recorder | DL800 Forest Medical 256 s/s 8 bit | BRAEMAR MANUFACTURING, LLC | |
44 | B146DL8CN0 | 900-0543-15 | Holter Monitor | DL800 CardioNet | BRAEMAR MANUFACTURING, LLC | |
45 | B146DL8CL0 | 900-0543-11 | Holter Recorder | DL800 CardioLabs | BRAEMAR MANUFACTURING, LLC | |
46 | B146DL8BD0 | 900-0543-19 | Holter Recorder | DL800 Biomedical SYS | BRAEMAR MANUFACTURING, LLC | |
47 | B146DL8B1330 | 900-0543-04 | Holter Recorder | DL800 Braemar 133 s/s | BRAEMAR MANUFACTURING, LLC | |
48 | B146DL8256B0 | 900-0543-09 | Holter Recorder | DL800 Braemar 256 s/s 10 bit | BRAEMAR MANUFACTURING, LLC | |
49 | B146CK0 | 100-0030-01 | Holter Recorder | Cardiokey | BRAEMAR MANUFACTURING, LLC | |
50 | 10841522127229 | 98000; 98200; TAY | 040-1761-00 | PACKAGE, EVO AND PATHFINDER SL | EVO and PATHFINDER SL | SPACELABS HEALTHCARE (WASHINGTON), INC |