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 B146M10 100-0046-02 DSI Detector And Alarm, Arrhythmia 2 C6 monitor
31 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
32 B146ERW3G040 900-0614-04 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM AMI
33 B146ER9WES0 900-0581-55 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Empire Scanning
34 B146ER9WCM0 900-0581-06 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Cardiomedix
35 B146ER9WCL20 900-0581-35 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Cardiolabs
36 B146ER9WB0 900-0581-00 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Braemar
37 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
38 B146DL9BS0 900-0570-26 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Base
39 B146DL9BK0 900-0570-19 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Burdick 4250
40 B146DL9AT0 900-0570-12 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Amedtec SD
41 B146DL8CN0 900-0543-15 Holter Monitor MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL800 CardioNet
42 B146DL830 350-0235-03 IKD Cable, Electrode 2 DL800 Patient Cable
43 B146DL800 350-0235-00 IKD Cable, Electrode 2 DL800 Patient Cable
44 B146C6E10 02-01846 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor 3.0
45 B146C6D0 02-01561 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor D
46 B146C5M0 100-0025-01 Ambulatory ECG Monitoring system DSI Detector And Alarm, Arrhythmia 2 C5 Monitor
47 B146BTPL210 02-01560 DSI Detector And Alarm, Arrhythmia 2 BTP-1000L-2 BTI
48 B146PERB0 900-0553-03 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 PER900 Braemar
49 B146UNM0 900-0581-56 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W UNM
50 B146ER9RAF0 900-0557-07 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ER920 Rozinn, AFIB
Other products with the same Product Codes "DRG, MLO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 09351356000055 2.0.X Stethee Pro Central Web Application is a component of the Stethee Pro Software S Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope. Stethee Pro Central Web Application M3DICINE PTY LTD
2 09351356000048 2.0.X Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software Sy Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope. Stethee Pro Mobile iOS Application M3DICINE PTY LTD
3 09351356000031 2.0.X Stethee Pro Mobile Android Application is a component of the Stethee Pro Softwar Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope. Stethee Pro Mobile Android Application M3DICINE PTY LTD
4 08056732654594 HD+ 81018027 Digital portable acquisition device which can acquire the electrocardiographic s Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host. HD+ CARDIOLINE SPA
5 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.
6 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.
7 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.
8 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.
9 07290110252748 NH301 ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM Ambulatory ECG Analysis Software NORAV MEDICAL LTD.
10 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.
11 07290110252724 SOFT-NH300-3 Holter analysis software + Data base. Includes download device according to reco NORAV MEDICAL LTD.
12 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.
13 07290110252700 SOFT-NH300-2 Holter Analysis software. Includes download device according to recorder type. NORAV MEDICAL LTD.
14 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.
15 06945040101499 TLC5007 Dynamic ECG Systems CONTEC CONTEC MEDICAL SYSTEMS CO., LTD.
16 06945040101406 TLC6000 Dynamic ECG Systems CONTEC CONTEC MEDICAL SYSTEMS CO., LTD.
17 06945040100294 TLC5000 Dynamic ECG Systems CONTEC CONTEC MEDICAL SYSTEMS CO., LTD.
18 06944413802261 iT20 Telemetry Transmitter EDAN INSTRUMENTS, INC.
19 06944413802162 elite V6 Patient Monitor EDAN INSTRUMENTS, INC.
20 06944413802155 elite V5 Patient Monitor EDAN INSTRUMENTS, INC.
21 06944413801707 elite V8 Patient Monitor EDAN INSTRUMENTS, INC.
22 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
23 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
24 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
25 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
26 05415067025746 X C12309 Guidewire PressureWire™ ST. JUDE MEDICAL, INC.
27 05415067025739 X C12009 Guidewire PressureWire™ ST. JUDE MEDICAL, INC.
28 05415067025722 X C12359 Guidewire PressureWire™ ST. JUDE MEDICAL, INC.
29 05415067025715 X C12059 Guidewire PressureWire™ ST. JUDE MEDICAL, INC.
30 05415067023384 PW USB Receiver C12781 PW USB Receiver SJM™ ST. JUDE MEDICAL, INC.
31 05415067023377 AO USB Receiver C12782 AO USB Receiver SJM™ ST. JUDE MEDICAL, INC.
32 05415067016546 Monitor Cable C12988 Cable SJM™ ST. JUDE MEDICAL, INC.
33 05415067000118 C17040 C17040 Signal Receiver Kit PressureWire™ ST. JUDE MEDICAL, INC.
34 05414734055819 C12358 C12358 Guidewire Mounted Sensor PressureWire™ ST. JUDE MEDICAL, INC.
35 05414734055772 C12058 C12058 Guidewire Mounted Sensor PressureWire™ ST. JUDE MEDICAL, INC.
36 05414734054164 PSU Kit C12785 Cable Wi-Box™ ST. JUDE MEDICAL, INC.
37 05414734054157 Xpress Cable C12784 Wi-Box™ ST. JUDE MEDICAL, INC.
38 05414734054140 AO Transmitter C12783 Signal Transceiver Wi-Box™ ST. JUDE MEDICAL, INC.
39 05060526840004 G1 40 Current Health Wearable Monnitoring System (Gen 1 Wearable) Current Health Wearable Monnitoring System CURRENT HEALTH LIMITED
40 05060403780041 US Patch TZ202055 Sensium Vitals SENSIUM HEALTHCARE LIMITED
41 04931921903346 YS-112P4 YS-112P4 GZ-140P Pouch NA NIHON KOHDEN CORPORATION
42 04931921903315 YN-981S YN-981S Air hose (0.8 m) NA NIHON KOHDEN CORPORATION
43 04931921903308 YN-980S YN-980S Air hose (1.5 m) NA NIHON KOHDEN CORPORATION
44 04931921902332 BR-946PA BR-946PA Electrode lead 6, snap, AHA NA NIHON KOHDEN CORPORATION
45 04931921902318 BR-943PA BR-943PA Electrode lead 3, snap, AHA NA NIHON KOHDEN CORPORATION
46 04931921902295 BR-936PA BR-936PA Electrode lead 6, clip, AHA NA NIHON KOHDEN CORPORATION
47 04931921902271 BR-933PA BR-933PA Electrode lead 3, clip, AHA NA NIHON KOHDEN CORPORATION
48 04931921898406 JL-030U2 JL-030U2 SpO2 Connection Cord for TL-535U, 1m NA NIHON KOHDEN CORPORATION
49 04931921898390 JL-030U1 JL-030U1 SpO2 Connection Cord for TL-535U, 0.3m NA NIHON KOHDEN CORPORATION
50 04931921877494 TL-631T3 TL-631T3 Finger probe Adult, child (20 kg or more) Finger or toe BluPRO® NIHON KOHDEN CORPORATION