Other products from "BRAEMAR MANUFACTURING, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B146FUSB0 900-0584-10 Wireless Ambulatory ECG Arrhythmia Monitoring system DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 Fusion Braemar
2 B146EP030 900-0632-01 DSH Recorder, Magnetic Tape, Medical 2 Epatch sensor
3 B146DL9RA0 900-0570-14 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Remote Analysis
4 B146DL9B70 900-0570-16 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Braemar 7day
5 B146DL9510 350-0318-01 IKD Cable, Electrode 2 DL950 Patient Cable
6 B146C6R20 02-01897 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor 2.0 rebuilt
7 B146C6D10 02-01606 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor
8 B146C5M20 02-00116 DSI Detector And Alarm, Arrhythmia 2 C5 Monitor NOBT
9 B146PERP0 900-0553-06 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 PER900 Preventice
10 B146PE2C0 02-01639 DRX Electrode, Electrocardiograph 2 Universal CE electrode-patch
11 B146FUSFCM0 900-0584-50 Wireless Ambulatory ECG Arrhythmia Monitoring system DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 Fusion First Call Medical
12 B146ERW3G030 900-0614-03 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM Life Support
13 B146ER9WLS0 900-0581-44 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Life Support
14 B146ER9WFCM0 900-0581-57 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W First-Call Medical
15 B146ER9WCL0 900-0581-58 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W CardioLabs
16 B146EPE30 390-0240-02 IKD Cable, Electrode ePatch electrode-patch
17 B146EP2R10 02-01997 DSH Recorder, Magnetic Tape, Medical 2 ePatch 2.0 rebuilt
18 B146EP2020 02-01650 DSH Recorder, Magnetic Tape, Medical 2 ePatch 2.0 BTI
19 B146EP080 900-0632-05 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
20 B146EP070 900-0632-04 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
21 B146EP060 900-0632-03 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
22 B146EP04 900-0632-02 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
23 B146ECAT2010 900-0623-01 DXH Transmitters And Receivers, Electrocardiograph, Telephone 2 ECAT2 Generic
24 B146DL9ZW0 900-0570-25 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
25 B146DL9BD0 900-0570-20 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Biomedical SyS
26 B146DL95000 900-0616-00 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL950 Braemar
27 B146DL9280 900-0570-28 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
28 B146DL900 350-0290-00 IKD Cable, Electrode 2 DL900 Patient cable
29 B146CK0 100-0030-01 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Cardiokey
30 B146ERWCD040 900-0612-04 DRG,MLO Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory, With Analysis Algorithm 2 ER9W Cardiolabs
31 B146M10 100-0046-02 DSI Detector And Alarm, Arrhythmia 2 C6 monitor
32 B146ERW3GCN0 900-0614-01 DRG,MLO Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory, With Analysis Algorithm 2 ER9W wEvent 3GSM
33 B146ERW3G040 900-0614-04 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM AMI
34 B146ER9WES0 900-0581-55 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Empire Scanning
35 B146ER9WCM0 900-0581-06 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Cardiomedix
36 B146ER9WCL20 900-0581-35 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Cardiolabs
37 B146ER9WB0 900-0581-00 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Braemar
38 B146ER9R0 900-0557-06 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ER920 Rozinn
39 B146DL9BS0 900-0570-26 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Base
40 B146DL9BK0 900-0570-19 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Burdick 4250
41 B146DL9AT0 900-0570-12 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Amedtec SD
42 B146DL8CN0 900-0543-15 Holter Monitor MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL800 CardioNet
43 B146DL830 350-0235-03 IKD Cable, Electrode 2 DL800 Patient Cable
44 B146DL800 350-0235-00 IKD Cable, Electrode 2 DL800 Patient Cable
45 B146C6E10 02-01846 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor 3.0
46 B146C6D0 02-01561 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor D
47 B146C5M0 100-0025-01 Ambulatory ECG Monitoring system DSI Detector And Alarm, Arrhythmia 2 C5 Monitor
48 B146BTPL210 02-01560 DSI Detector And Alarm, Arrhythmia 2 BTP-1000L-2 BTI
49 B146PERB0 900-0553-03 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 PER900 Braemar
50 B146UNM0 900-0581-56 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W UNM
Other products with the same Product Code "MLO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07290110254995 SW NH301-4 HASP-SW-K-NH301-4-04 Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB or SD Card Reader (for DL800/900 recorders) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). Norav 1200 Series PC-ECG NORAV MEDICAL LTD.
2 07290110254988 SW NH301-3 HASP-SW-K-NH301-4-03 Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB (for DL900 recorders) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). Norav 1200 Series PC-ECG NORAV MEDICAL LTD.
3 07290110254971 SW NH301-2 HASP-SW-K-NH301-4-02 Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis, including support for NR via USB The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). Norav 1200 Series PC-ECG NORAV MEDICAL LTD.
4 07290110252755 SW NH301-N HASP-SW-K-NH301-Net-1 Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Nethasp Holter for additional work station, Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). Norav 1200 Series PC-ECG NORAV MEDICAL LTD.
5 07290110252748 NH301 ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM Ambulatory ECG Analysis Software NORAV MEDICAL LTD.
6 07290110252731 SW NH300-N HASP-SW-KNH300-3N-M-02 Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Network Solution for NH300 - No additional users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). Norav 1200 Series PC-ECG NORAV MEDICAL LTD.
7 07290110252724 SOFT-NH300-3 Holter analysis software + Data base. Includes download device according to reco NORAV MEDICAL LTD.
8 07290110252717 SW NH300 Ana to 301 SW NH300 Ana to 301 Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). Norav 1200 Series PC-ECG NORAV MEDICAL LTD.
9 07290110252700 SOFT-NH300-2 Holter Analysis software. Includes download device according to recorder type. NORAV MEDICAL LTD.
10 07290110252687 SOFT-NH300-1 HASP-SW-K-NH300-1-01 Holter down load and review software. Includes download device according to reco Holter down load and review software. Includes download device according to reco NORAV MEDICAL LTD.
11 06945040101499 TLC5007 Dynamic ECG Systems CONTEC CONTEC MEDICAL SYSTEMS CO., LTD.
12 06945040101406 TLC6000 Dynamic ECG Systems CONTEC CONTEC MEDICAL SYSTEMS CO., LTD.
13 06945040100294 TLC5000 Dynamic ECG Systems CONTEC CONTEC MEDICAL SYSTEMS CO., LTD.
14 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. Cardiospy ECG Holter System LABTECH KERESKEDELMI ÉS MÉRNÖKI SZOLGÁLTATÓ KORLÁTOLT FELELőSSÉGű TÁRSASÁG
15 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. Cardiospy ECG Holter System LABTECH KERESKEDELMI ÉS MÉRNÖKI SZOLGÁLTATÓ KORLÁTOLT FELELőSSÉGű TÁRSASÁG
16 05999883490013 EC-3H The battery powered Cardiospy ECG Holter System provides 1, 2, 3 channel recordi The battery powered Cardiospy ECG Holter System provides 1, 2, 3 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. Cardiospy ECG Holter System LABTECH KERESKEDELMI ÉS MÉRNÖKI SZOLGÁLTATÓ KORLÁTOLT FELELőSSÉGű TÁRSASÁG
17 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. Cardiospy ECG Holter System LABTECH KERESKEDELMI ÉS MÉRNÖKI SZOLGÁLTATÓ KORLÁTOLT FELELőSSÉGű TÁRSASÁG
18 00884838094895 Philips Holter Software 860292 Philips Holter Software w/ Zymed Alg Holter Software PHILIPS MEDICAL SYSTEMS HSG
19 00862887000340 PM410 CardioPAL SAVI is a small, patient worn device, prescribed by physicians for pat CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. CardioPAL SAVI MEDICOMP, INC.
20 00841709118067 P/N 4-100-3140 IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter. MIDMARK IQHOLTER® PLUG-IN SOFTWARE MIDMARK CORPORATION
21 00841709100703 2-100-0090 2-100-0090 These kits are designed to provide the supplies you need for Holter testing. Kit These kits are designed to provide the supplies you need for Holter testing. Kit includes: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and seven electrodes. Prep Kit - Midmark IQholter, 7-lead MIDMARK CORPORATION
22 00841709100697 2-100-0080 2-100-0080 These kits are designed to provide the supplies you need for Holter testing. Kit These kits are designed to provide the supplies you need for Holter testing. Kit contains: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and five electrodes. Prep Kit - Midmark IQholter, 5-lead MIDMARK CORPORATION
23 00841709100659 1-370-0005 1-370-0005 Small and lightweight digital Holter recorder. Standard 24-hour recording with Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQholter® Digital Holter Recorder MIDMARK CORPORATION
24 00841709100628 4-000-0119 4-000-0119 Small and lightweight digital Holter recorder. Standard 24-hour recording with Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt. Midmark IQholter® Digital Holter Recorder Kit MIDMARK CORPORATION
25 00841709100611 4-000-0116 4-000-0116 The Midmark IQholter® EP system combines a compact digital recorder with three p The Midmark IQholter® EP system combines a compact digital recorder with three powerful software applications. Includes all the features of IQholter® EX plus Pacemaker detection of single and dual-chamber paced beats for non-captures and sensing failures.situations in fast-paced offices. Kit includes: Midmark IQholter EP with Pacemaker Detection, Midmark IQholter Recorder (includes Lead Wire Set, Secure Digital Card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits. Midmark IQholter® EP Digital Holter MIDMARK CORPORATION
26 00841709100604 4-000-0113 4-000-0113 The Midmark IQholter EX system combines a compact digital recorder with three po The Midmark IQholter EX system combines a compact digital recorder with three powerful software applications. Includes the standard features of IQholter with expanded functionality for A-Fib, QT/QTc and HRV analysis, template editing, Smart Page Scan and more. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits. Midmark IQholter EX Digital Holter MIDMARK CORPORATION
27 00841709100598 4-000-0110 4-000-0110 The Midmark IQholter system combines a compact digital recorder with three power The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits. Midmark IQholter Digital Holter MIDMARK CORPORATION
28 00817655022642 11100-005-50 Holter Analysis System Software Vision MORTARA INSTRUMENT, INC.
29 00817655022635 11110-005-50 Holter Analysis System Software HScribe MORTARA INSTRUMENT, INC.
30 00817655022529 HSCRIBWS-6BC-YXXXX Holter Analysis System HScribe MORTARA INSTRUMENT, INC.
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35 00817655022475 MDLTYMGR-5BC-XXXXX Cardiology Information System Workstation Modality Manager MORTARA INSTRUMENT, INC.
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