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 | 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 | 10804084000010 | BPM 0001 | IDEAL LIFE BP-Manager™ | IDEAL LIFE INC | ||
2 | 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 | |
3 | 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 | |
4 | 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 | |
5 | 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 |
6 | 06944413802261 | iT20 | Telemetry Transmitter | EDAN INSTRUMENTS, INC. | ||
7 | 06944413802162 | elite V6 | Patient Monitor | EDAN INSTRUMENTS, INC. | ||
8 | 06944413802155 | elite V5 | Patient Monitor | EDAN INSTRUMENTS, INC. | ||
9 | 06944413801707 | elite V8 | Patient Monitor | EDAN INSTRUMENTS, INC. | ||
10 | 05415067025746 | X | C12309 | Guidewire | PressureWire™ | ST. JUDE MEDICAL, INC. |
11 | 05415067025739 | X | C12009 | Guidewire | PressureWire™ | ST. JUDE MEDICAL, INC. |
12 | 05415067025722 | X | C12359 | Guidewire | PressureWire™ | ST. JUDE MEDICAL, INC. |
13 | 05415067025715 | X | C12059 | Guidewire | PressureWire™ | ST. JUDE MEDICAL, INC. |
14 | 05415067023384 | PW USB Receiver | C12781 | PW USB Receiver | SJM™ | ST. JUDE MEDICAL, INC. |
15 | 05415067023377 | AO USB Receiver | C12782 | AO USB Receiver | SJM™ | ST. JUDE MEDICAL, INC. |
16 | 05415067016546 | Monitor Cable | C12988 | Cable | SJM™ | ST. JUDE MEDICAL, INC. |
17 | 05415067000118 | C17040 | C17040 | Signal Receiver Kit | PressureWire™ | ST. JUDE MEDICAL, INC. |
18 | 05414734055819 | C12358 | C12358 | Guidewire Mounted Sensor | PressureWire™ | ST. JUDE MEDICAL, INC. |
19 | 05414734055772 | C12058 | C12058 | Guidewire Mounted Sensor | PressureWire™ | ST. JUDE MEDICAL, INC. |
20 | 05414734054164 | PSU Kit | C12785 | Cable | Wi-Box™ | ST. JUDE MEDICAL, INC. |
21 | 05414734054157 | Xpress Cable | C12784 | Wi-Box™ | ST. JUDE MEDICAL, INC. | |
22 | 05414734054140 | AO Transmitter | C12783 | Signal Transceiver | Wi-Box™ | ST. JUDE MEDICAL, INC. |
23 | 05060526840004 | G1 | 40 | Current Health Wearable Monnitoring System (Gen 1 Wearable) | Current Health Wearable Monnitoring System | CURRENT HEALTH LIMITED |
24 | 05060403780041 | US Patch | TZ202055 | Sensium Vitals | SENSIUM HEALTHCARE LIMITED | |
25 | 04931921903346 | YS-112P4 | YS-112P4 | GZ-140P Pouch | NA | NIHON KOHDEN CORPORATION |
26 | 04931921903315 | YN-981S | YN-981S | Air hose (0.8 m) | NA | NIHON KOHDEN CORPORATION |
27 | 04931921903308 | YN-980S | YN-980S | Air hose (1.5 m) | NA | NIHON KOHDEN CORPORATION |
28 | 04931921902332 | BR-946PA | BR-946PA | Electrode lead 6, snap, AHA | NA | NIHON KOHDEN CORPORATION |
29 | 04931921902318 | BR-943PA | BR-943PA | Electrode lead 3, snap, AHA | NA | NIHON KOHDEN CORPORATION |
30 | 04931921902295 | BR-936PA | BR-936PA | Electrode lead 6, clip, AHA | NA | NIHON KOHDEN CORPORATION |
31 | 04931921902271 | BR-933PA | BR-933PA | Electrode lead 3, clip, AHA | NA | NIHON KOHDEN CORPORATION |
32 | 04931921898406 | JL-030U2 | JL-030U2 | SpO2 Connection Cord for TL-535U, 1m | NA | NIHON KOHDEN CORPORATION |
33 | 04931921898390 | JL-030U1 | JL-030U1 | SpO2 Connection Cord for TL-535U, 0.3m | NA | NIHON KOHDEN CORPORATION |
34 | 04931921877494 | TL-631T3 | TL-631T3 | Finger probe Adult, child (20 kg or more) Finger or toe | BluPRO® | NIHON KOHDEN CORPORATION |
35 | 04931921877432 | TL-631T1 | TL-631T1 | Finger probe Adult, child (20 kg or more) Finger or toe | BluPRO® | NIHON KOHDEN CORPORATION |
36 | 04931921871188 | TL-220T | TL-220T | Multi-site probe Adults, child (3 kg or more) | BluPRO® | NIHON KOHDEN CORPORATION |
37 | 04931921867686 | BR-916PA | BR-916PA | Electrode lead, 6 electrodes (AHA) (Snap type) | NA | NIHON KOHDEN CORPORATION |
38 | 04931921859735 | BR-906PA | BR-906PA | ECG Electrode Lead (6 Electrodes) AHA, clip type | NA | NIHON KOHDEN CORPORATION |
39 | 04931921859728 | BR-903PA | BR-903PA | ECG Electrode Lead (3 Electrodes) AHA, clip type | NA | NIHON KOHDEN CORPORATION |
40 | 04931921854242 | BR-913PA | BR-913PA | Electrode lead, 3 electrodes (AHA) (Snap type), | NA | NIHON KOHDEN CORPORATION |
41 | 04931921852712 | TL-201T | TL-201T | Finger probe Adult, child (20kg or more) Finger | BluPRO® | NIHON KOHDEN CORPORATION |
42 | 04931921128244 | GZ-140P | GZ-140P | Vital Sign Telemeter | NA | NIHON KOHDEN CORPORATION |
43 | 04931921117415 | GZ-130P | GZ-130P | Vital Sign Telemeter | NA | NIHON KOHDEN CORPORATION |
44 | 04931921117392 | GZ-120P | GZ-120P | Vital Sign Telemeter | NA | NIHON KOHDEN CORPORATION |
45 | 04931921115268 | ZR-920P | ZR-920P | Receiver unit for ZS, ZM series | NA | NIHON KOHDEN CORPORATION |
46 | 04931921103906 | ORG-9110A | ORG-9110A | WMTS digital telemetry receiver; L-BAND 1.4 GHz | NA | NIHON KOHDEN CORPORATION |
47 | 04931921103883 | ORG-9100A | ORG-9100A | WMTS digital telemetry receiver; 608 UHF MHz | NA | NIHON KOHDEN CORPORATION |
48 | 04931921019696 | TL-220T | TL-220T-A1 | Multi-site probe Adults, child (3 kg or more) | BluPRO® | NIHON KOHDEN AMERICA, INC. |
49 | 04931921005828 | TL-271T3 | TL-271T3-A24 | SpO2 probe Adults (30 kg or more) Finger or toe, disposable | BluPRO® | NIHON KOHDEN CORPORATION |
50 | 04719872650287 | GA2001Rx | Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY | Guardian Angel™ Rx | AULISA MEDICAL USA, INC. |