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 B146FUSFCM0 900-0584-50 Wireless Ambulatory ECG Arrhythmia Monitoring system DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 Fusion First Call Medical
11 B146ERW3G030 900-0614-03 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM Life Support
12 B146ER9WLS0 900-0581-44 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Life Support
13 B146ER9WFCM0 900-0581-57 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W First-Call Medical
14 B146ER9WCL0 900-0581-58 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W CardioLabs
15 B146EPE30 390-0240-02 IKD Cable, Electrode ePatch electrode-patch
16 B146EP2R10 02-01997 DSH Recorder, Magnetic Tape, Medical 2 ePatch 2.0 rebuilt
17 B146EP2020 02-01650 DSH Recorder, Magnetic Tape, Medical 2 ePatch 2.0 BTI
18 B146EP080 900-0632-05 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
19 B146EP070 900-0632-04 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
20 B146EP060 900-0632-03 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
21 B146EP04 900-0632-02 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
22 B146ECAT2010 900-0623-01 DXH Transmitters And Receivers, Electrocardiograph, Telephone 2 ECAT2 Generic
23 B146DL9ZW0 900-0570-25 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
24 B146DL9BD0 900-0570-20 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Biomedical SyS
25 B146DL95000 900-0616-00 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL950 Braemar
26 B146DL9280 900-0570-28 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
27 B146DL900 350-0290-00 IKD Cable, Electrode 2 DL900 Patient cable
28 B146CK0 100-0030-01 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Cardiokey
29 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
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 Code "DRX"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 08809083941680 2009110-050R ELECTRODE, ADULT, FOAM, ROUND, RADIOLUCENT, SOLID GEL, 50/POUCH Vyaire BIOPROTECH INC.
2 08809083941673 2009110-050R ELECTRODE, ADULT, FOAM, ROUND, RADIOLUCENT, SOLID GEL, 50/POUCH CareFusion BIOPROTECH INC.
3 08809083941666 2009109-050 ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 50/POUCH Vyaire BIOPROTECH INC.
4 08809083941659 2009109-050 ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 50/POUCH CareFusion BIOPROTECH INC.
5 08809083941642 2009109-005 ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 5/STRIP Vyaire BIOPROTECH INC.
6 08809083941635 2009109-005 ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 5/STRIP CareFusion BIOPROTECH INC.
7 08809083941628 2009109-003 ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 3/STRIP Vyaire BIOPROTECH INC.
8 08809083941611 2009109-003 ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 3/STRIP CareFusion BIOPROTECH INC.
9 08809083941604 2009111-150 ELECTRODE, PEDIATRIC, CLOTH, ROUND, SOLID GEL, 50/POUCH Vyaire BIOPROTECH INC.
10 08809083941598 2009111-150 ELECTRODE, PEDIATRIC, CLOTH, ROUND, SOLID GEL, 50/POUCH CareFusion BIOPROTECH INC.
11 08809083941581 2009111-050 ELECTRODE, ADULT, CLOTH, ROUND, SOLID GEL, 50/POUCH Vyaire BIOPROTECH INC.
12 08809083941574 2009111-050 ELECTRODE, ADULT, CLOTH, ROUND, SOLID GEL, 50/POUCH CareFusion BIOPROTECH INC.
13 08809083941567 2009110-050W ELECTRODE, ADULT, FOAM, ROUND, WET GEL, 50/POUCH Vyaire BIOPROTECH INC.
14 08809083941550 2009110-050W ELECTRODE, ADULT, FOAM, ROUND, WET GEL, 50/POUCH CareFusion BIOPROTECH INC.
15 08809083941543 2009110-150 ELECTRODE, PEDIATRIC, FOAM, ROUND, SOLID GEL, 50/POUCH Vyaire BIOPROTECH INC.
16 08809083941536 2009110-150 ELECTRODE, PEDIATRIC, FOAM, ROUND, SOLID GEL, 50/POUCH CareFusion BIOPROTECH INC.
17 08809083941529 2009110-050 ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 50/POUCH Vyaire BIOPROTECH INC.
18 08809083941512 2009110-050 ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 50/POUCH CareFusion BIOPROTECH INC.
19 08809083941505 2009110-005 ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 5/STRIP Vyaire BIOPROTECH INC.
20 08809083941499 2009110-005 ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 5/STRIP CareFusion BIOPROTECH INC.
21 08809083941482 2009110-003 ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 3/STRIP Vyaire BIOPROTECH INC.
22 08809083941475 2009110-003 ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 3/STRIP CareFusion BIOPROTECH INC.
23 08809083941468 2009101-403 Radiolucent Neonatal Cloth Monitoring Snap Electrodes Vyaire BIOPROTECH INC.
24 08809083941451 2009101-403 Radiolucent Neonatal Cloth Monitoring Snap Electrodes CareFusion BIOPROTECH INC.
25 08809083941444 2009101-406 Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC v Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC version colors lead wires) Vyaire BIOPROTECH INC.
26 08809083941437 2009101-406 Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC v Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC version colors lead wires) CareFusion BIOPROTECH INC.
27 08809083941420 2009101-404 Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Ldwrs Vyaire BIOPROTECH INC.
28 08809083941413 2009101-404 Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Ldwrs CareFusion BIOPROTECH INC.
29 08809083941390 2009101-103P Pediatric Resting ECG Electrodes, Mild Adhesive Vyaire BIOPROTECH INC.
30 08809083941383 2009101-103P Pediatric Resting ECG Electrodes, Mild Adhesive CareFusion BIOPROTECH INC.
31 08809083941369 2009101-210 Adult Resting ECG Electrodes, Moderate Adhesive Vyaire BIOPROTECH INC.
32 08809083941352 2009101-210 Adult Resting ECG Electrodes, Moderate Adhesive CareFusion BIOPROTECH INC.
33 08809083941338 2009101-003P Adult Resting ECG Electrodes, Aggressive Adhesive Vyaire BIOPROTECH INC.
34 08809083941321 2009101-003P Adult Resting ECG Electrodes, Aggressive Adhesive CareFusion BIOPROTECH INC.
35 08809083941307 2009101-003 Adult Resting ECG Electrodes, Moderate Adhesive Vyaire BIOPROTECH INC.
36 08809083941291 2009101-003 Adult Resting ECG Electrodes, Moderate Adhesive CareFusion BIOPROTECH INC.
37 08054953344027 F9010SSC-6 F9010SSC-6 Reusable peripheral electrodes for ECG, 31.5x22mm dimensions, have features that Reusable peripheral electrodes for ECG, 31.5x22mm dimensions, have features that make them absolutely reliable during signal recording with all different ECG recorders on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. F9010SSC-6 thanks to screw and snap connections, can be tapped to all ECG recorders and monitors both with plug and snap. To be used with fasten belts.The product is Latex-free and Nickel-free. NA FIAB SPA
38 08054953343501 F9047RM F9047RM Disposable ECG RADIOLUCENT electrodes with liquid gel, 32x44mm dimensions, Silve Disposable ECG RADIOLUCENT electrodes with liquid gel, 32x44mm dimensions, Silver/Silver Chloride (SSC) sensor and carbon snap. F9047RM model is suitable both for rest and stress or Holter ECG recording, with a direct application onto the skin.The SSC sensor permits a reliable and stable recording. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids NA FIAB SPA
39 08054953343495 F9046RM F9046RM Disposable ECG RADIOLUCENT electrodes with solid gel, 28x44mm dimensions, Silver Disposable ECG RADIOLUCENT electrodes with solid gel, 28x44mm dimensions, Silver/Silver Chloride(SSC) sensor and carbon snap. F9046RM model is suitable both for rest and stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids NA FIAB SPA
40 08054953343266 F9060X/AUS F9060X/AUS Disposable ECG electrodes, oval-shaped 50x48mm dimensions,Silver/Silver Chlori Disposable ECG electrodes, oval-shaped 50x48mm dimensions,Silver/Silver Chloride(SSC) sensor and stainless steel snap. F9060 model is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids NA FIAB SPA
41 08054953342191 F9046 F9046 Disposable ECG electrodes with solid gel, 28x44mm dimensions,Silver/Silver Chlo Disposable ECG electrodes with solid gel, 28x44mm dimensions,Silver/Silver Chloride(SSC) sensor and stainless steel snap. F9046 model is suitable both for rest and stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids. NA FIAB SPA
42 08054953341248 F2017/4FL F2017/4FL Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chlor Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) sensor, 52x32mm dimensions and with 4mm socket . These electrodes dimensions have features that make them absolutely reliable during signal recording in rest tests, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. They comply with ANSI/AAMI EC12:2000 permitting the signal recovery after defibrillator discharge. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are latex-free. NA FIAB SPA
43 08054953341231 F2017P F2017P Disposable round-shaped ECG electrodes with liquid gel, Ø 42mm, Silver/Sil Disposable round-shaped ECG electrodes with liquid gel, Ø 42mm, Silver/Silver Chloride(SSC) sensor and metal snap. These electrodes are suitable for short and medium term monitoring, stress ECG recording and Holter, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. NA FIAB SPA
44 08054953341224 F2017 F2017 Disposable round-shaped ECG electrodes with liquid gel, Ø 50mm, Silver/Sil Disposable round-shaped ECG electrodes with liquid gel, Ø 50mm, Silver/Silver Chloride(SSC) sensor and metal snap. These electrodes are suitable for short and medium term monitoring, stress ECG recording and Holter, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. NA FIAB SPA
45 08054953341217 F2017H F2017H Disposable round-shaped ECG electrodes with liquid gel, Ø 60mm, Silver/Sil Disposable round-shaped ECG electrodes with liquid gel, Ø 60mm, Silver/Silver Chloride(SSC) sensor and metal snap. These electrodes are suitable for short and medium term monitoring, stress ECG recording and Holter, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. NA FIAB SPA
46 08054953341101 F9057PRRM F9057PRRM F9057PRRM model is a disposable round-shaped ECG monitoring electrodes have feat F9057PRRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Neonatal and Premature model.F9057PRRM model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode. NA FIAB SPA
47 08054953341095 F9057PR F9057PR F9057PR model is a disposable oval-shaped ECG monitoring electrodes have feature F9057PR model is a disposable oval-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PR is pre-gelled, 20x15mm dimensions, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Neonatal and premature model. NA FIAB SPA
48 08054953341088 F9057NRM F9057NRM F9057NRM model is a disposable oval-shaped ECG monitoring electrodes have featur F9057NRM model is a disposable oval-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057NRM is pre-gelled, 23x30mm dimensions, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Pediatric and Neonatal model.F9057NRM model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode. NA FIAB SPA
49 08054953341071 F9057N F9057N F9057N model is a disposable oval-shaped ECG monitoring electrodes have features F9057N model is a disposable oval-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057N is pre-gelled, 23x30mm dimensions, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use.Pediatric and Neonatal model. NA FIAB SPA
50 08054953341064 F9057PRM F9057PRM F9057PRM model is a disposable round-shaped ECG monitoring electrodes have featu F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Adult and Pediatric model.F9057PRM model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode. NA FIAB SPA