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 | 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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817655022932 | H12PLUS-BHB-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
2 | 00817655022925 | H12PLUS-GAA-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
3 | 00817655022208 | H12PLUS-AHD-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
4 | 00817655022192 | H3PLUS-COA-XXXXX | Holter Recorder | H3+ | MORTARA INSTRUMENT, INC. | |
5 | 00817655022086 | H12PLUS-ABA-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
6 | 00817655020853 | 901142 | H3PLUS-CAE-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
7 | 00817655020440 | H12PLUS-HAA-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
8 | 00817655020433 | H3PLUS-CAD-XXXXX | Holter Recorder | H3+ | MORTARA INSTRUMENT, INC. | |
9 | 00817655020334 | H12PLUS-BAC-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
10 | 00815871021425 | 60130H | Sage 12c | AVANTE | ||
11 | 00812345027112 | H3PLUS-BAD-XXXXX | Holter Recorder | H3+ | MORTARA INSTRUMENT, INC. | |
12 | 00812345027105 | H3PLUS-BAA-XXXXX | Holter Recorder | H3+ | MORTARA INSTRUMENT, INC. | |
13 | 00812345027099 | H12PLUS-AAC-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
14 | 00812345027044 | BURH3PR | Holter Recorder | H3+ | MORTARA INSTRUMENT, INC. | |
15 | 00812345025064 | 9293-037-61 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
16 | 00812345025057 | 9293-037-51 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
17 | 00812345025040 | 9293-036-63 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
18 | 00812345025033 | 9293-036-62 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
19 | 00812345025026 | 9293-036-61 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
20 | 00812345025002 | 9293-036-53 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
21 | 00812345024999 | 9293-036-52 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
22 | 00812345024982 | 9293-036-51 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
23 | 00812345023084 | 9293-036-60 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
24 | 00812345023077 | 9293-036-50 | Patient cable cleared with H3+ recorder | H3+ Patient Cable | MORTARA INSTRUMENT, INC. | |
25 | 00812345021684 | H3PLUS-AAA-XXXXX | Holter Recorder | H3+ | MORTARA INSTRUMENT, INC. | |
26 | 00812345021660 | H12PLUS-CAA-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
27 | 00812345021653 | H12PLUS-BAA-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
28 | 00812345021646 | H12PLUS-AAA-XXXXX | Holter Recorder | H12+ | MORTARA INSTRUMENT, INC. | |
29 | 00732094327793 | 901141 | H12PLUS-LPA-XXXXX | H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends; | Welch Allyn, Inc. | WELCH ALLYN, INC. |
30 | 00732094327786 | 901141 | H12PLUS-MPA-XXXXX | H12+ Standard 12-lead digital Holter Recorder - 48-hour, includes secure digital H12+ Standard 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends; | Welch Allyn, Inc. | WELCH ALLYN, INC. |
31 | 00732094327779 | 901141 | H12PLUS-NPA-XXXXX | H12+ High Fidelity 12-lead digital Holter Recorder - 24-hour, includes secure di H12+ High Fidelity 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends; | Welch Allyn, Inc. | WELCH ALLYN, INC. |
32 | 00732094327762 | 901141 | H12PLUS-OPA-XXXXX | H12+ High Fidelity 12-lead digital Holter Recorder - 48-hour, includes secure di H12+ High Fidelity 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends; | Welch Allyn, Inc. | WELCH ALLYN, INC. |
33 | 00732094327410 | 901141 | 9515-160-51-CD | H12 V5.0 USER MANUALS | Welch Allyn, Inc. | WELCH ALLYN, INC. |
34 | 00732094320701 | 901142 | H3PLUS-BAB-XXXXX | H3+ 3-channel digital Holter Recorder - 48-hour, includes carry case with clip, H3+ 3-channel digital Holter Recorder - 48-hour, includes carry case with clip, and hookup kit (available for US only) | Welch Allyn, Inc. | WELCH ALLYN, INC. |
35 | 00732094309300 | 901141 | H12PLUS-JPA-XXXXR | Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidel Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
36 | 00732094309294 | 901141 | H12PLUS-JPB-XXXXR | Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidel Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
37 | 00732094309287 | 901141 | H12PLUS-KPA-XXXXR | Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidel Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
38 | 00732094309270 | 901141 | H12PLUS-KPB-XXXXR | Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidel Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
39 | 00732094308563 | 901142 | H3PLUS-COD-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; AHA 5 wire, 15" (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
40 | 00732094308556 | 901142 | H3PLUS-COE-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
41 | 00732094294118 | 901141 | H12PLUS-HPA-XXXXX | H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-ho H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38"" (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
42 | 00732094264838 | 901141 | H12PLUS-BAB-XXXXX | H12+ 12-lead digital Holter Recorder - 48-hour (requires AA Lithium battery), in H12+ 12-lead digital Holter Recorder - 48-hour (requires AA Lithium battery), includes standard compact flash card (128 MB), carry case, , and hookup kit; English language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
43 | 00732094264388 | 901142 | H3PLUS-BAE-XXXXX | H3+ 3-channel digital Holter Recorder - 48-hour, includes carry case with clip, H3+ 3-channel digital Holter Recorder - 48-hour, includes carry case with clip, and hookup kit (available for US only); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
44 | 00732094264371 | 901142 | H3PLUS-CAB-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
45 | 00732094264364 | 901142 | H3PLUS-CBA-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; AHA 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
46 | 00732094264357 | 901142 | H3PLUS-CBB-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
47 | 00732094264340 | 901142 | H3PLUS-CBD-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; AHA 5 wire, 15 in. (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
48 | 00732094264333 | 901142 | H3PLUS-CBE-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Spanish language and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
49 | 00732094264326 | 901142 | H3PLUS-CCB-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); French language and CD manual; IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
50 | 00732094264319 | 901142 | H3PLUS-CCE-XXXXX | H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); French language and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |