No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05999883490075 | USB-02 Dongle | DEV-00USB-02 | The USB-02 Dongle is the hardware key for Cardiospy software that makes possible The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Cardiospy ECG Holter recorders (EC-2H, EC-3H or EC-12H) as a system and the management, procession and evaluation of the recorded row data.The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available.The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems.The connection between the Holter and computer is performed by using Bluetooth and USB dongle.The Cardiospy analysis software provides ECG records of excellent quality. | MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Cardiospy ECG Holter System |
2 | 05999883490044 | EC-12H | The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available.The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems.The connection between the Holter and computer is performed by using Bluetooth and USB dongle.The Cardiospy analysis software provides ECG records of excellent quality. | MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Cardiospy ECG Holter System | |
3 | 05999883490006 | EC-2H | The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available.The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems.The connection between the Holter and computer is performed by using Bluetooth and USB dongle.The Cardiospy analysis software provides ECG records of excellent quality. | MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Cardiospy ECG Holter System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
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1 | 00817655022642 | 11100-005-50 | Holter Analysis System Software | Vision | MORTARA INSTRUMENT, INC. | |
2 | 00817655022635 | 11110-005-50 | Holter Analysis System Software | HScribe | MORTARA INSTRUMENT, INC. | |
3 | 00817655022529 | HSCRIBWS-6BC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
4 | 00817655022512 | HSCRIBWS-6BC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
5 | 00817655022505 | HSCRIBWS-6BC-DXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
6 | 00817655022499 | HSCRIBWS-6BC-BXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
7 | 00817655022482 | HSCRIBWS-6BA-CXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
8 | 00817655022475 | MDLTYMGR-5BC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
9 | 00817655022468 | MDLTYMGR-5BC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
10 | 00817655022451 | MDLTYMGR-5AE-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
11 | 00817655022444 | MDLTYMGR-5AD-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
12 | 00817655022437 | MDLTYMGR-5AC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
13 | 00817655022420 | MDLTYMGR-5AC-XXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
14 | 00817655022413 | MDLTYMGR-5AC-XXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
15 | 00817655022406 | MDLTYMGR-5AC-DXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
16 | 00817655022390 | MDLTYMGR-5AC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
17 | 00817655022383 | MDLTYMGR-5AC-DXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
18 | 00817655022376 | MDLTYMGR-5AC-CXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
19 | 00817655022369 | MDLTYMGR-5AC-CXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
20 | 00817655022352 | MDLTYMGR-5AC-BXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
21 | 00817655022345 | MDLTYMGR-5AC-BXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
22 | 00817655022338 | MDLTYMGR-5AC-BXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
23 | 00817655022321 | MDLTYMGR-5AC-AXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
24 | 00817655022314 | MDLTYMGR-5AC-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
25 | 00817655022307 | MDLTYMGR-5AC-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
26 | 00817655022291 | MDLTYMGR-5AA-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
27 | 00817655022284 | HSCRIBWS-6AC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
28 | 00817655022277 | HSCRIBWS-6AC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
29 | 00817655022260 | HSCRIBWS-6AC-DXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
30 | 00817655022253 | MDLTYMGR-5AA-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
31 | 00817655022239 | HSCRIBE-6AC-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
32 | 00817655022161 | HSCRIBE-6AC-YXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
33 | 00817655021904 | HSERV-6BA-XXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
34 | 00817655021829 | HSCRIBE-6AC-YXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
35 | 00817655021744 | HSCRIBE-6AC-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
36 | 00817655021461 | HSCRIBE-EYA-BXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
37 | 00817655021102 | HSCRIBE-6AA-AAXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
38 | 00817655021096 | HSCRIBE-6AB-AXXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
39 | 00817655021089 | HSCRIBE-6AB-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
40 | 00817655021072 | HSCRIBE-6AB-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
41 | 00817655020860 | 901143 | HSCRIBE-6AA-CXXXX | HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia a HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer; No connectivity | Welch Allyn, Inc. | WELCH ALLYN, INC. |
42 | 00817655020716 | HSCRIBE-6AC-AXXXD | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
43 | 00817655020655 | V51-1GI | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
44 | 00817655020587 | SCRIBEWS-5AC-XXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
45 | 00817655020570 | HSCRIBE-6AA-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
46 | 00817655020563 | HSERV-6BA-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
47 | 00817655020457 | SCRIBEWS-5BC-XXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
48 | 00817655020426 | HSCRIBE-6AA-AAXXE | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
49 | 00817655020396 | HSCRIBEWS-6BC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
50 | 00817655020389 | HSCRIBEWS-6AC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. |