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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04931921903346 | YS-112P4 | YS-112P4 | GZ-140P Pouch | NA | NIHON KOHDEN CORPORATION |
2 | 04931921903315 | YN-981S | YN-981S | Air hose (0.8 m) | NA | NIHON KOHDEN CORPORATION |
3 | 04931921903308 | YN-980S | YN-980S | Air hose (1.5 m) | NA | NIHON KOHDEN CORPORATION |
4 | 04931921902332 | BR-946PA | BR-946PA | Electrode lead 6, snap, AHA | NA | NIHON KOHDEN CORPORATION |
5 | 04931921902318 | BR-943PA | BR-943PA | Electrode lead 3, snap, AHA | NA | NIHON KOHDEN CORPORATION |
6 | 04931921902295 | BR-936PA | BR-936PA | Electrode lead 6, clip, AHA | NA | NIHON KOHDEN CORPORATION |
7 | 04931921902271 | BR-933PA | BR-933PA | Electrode lead 3, clip, AHA | NA | NIHON KOHDEN CORPORATION |
8 | 04931921898406 | JL-030U2 | JL-030U2 | SpO2 Connection Cord for TL-535U, 1m | NA | NIHON KOHDEN CORPORATION |
9 | 04931921898390 | JL-030U1 | JL-030U1 | SpO2 Connection Cord for TL-535U, 0.3m | NA | NIHON KOHDEN CORPORATION |
10 | 04931921877494 | TL-631T3 | TL-631T3 | Finger probe Adult, child (20 kg or more) Finger or toe | BluPRO® | NIHON KOHDEN CORPORATION |
11 | 04931921877432 | TL-631T1 | TL-631T1 | Finger probe Adult, child (20 kg or more) Finger or toe | BluPRO® | NIHON KOHDEN CORPORATION |
12 | 04931921871188 | TL-220T | TL-220T | Multi-site probe Adults, child (3 kg or more) | BluPRO® | NIHON KOHDEN CORPORATION |
13 | 04931921867686 | BR-916PA | BR-916PA | Electrode lead, 6 electrodes (AHA) (Snap type) | NA | NIHON KOHDEN CORPORATION |
14 | 04931921859735 | BR-906PA | BR-906PA | ECG Electrode Lead (6 Electrodes) AHA, clip type | NA | NIHON KOHDEN CORPORATION |
15 | 04931921859728 | BR-903PA | BR-903PA | ECG Electrode Lead (3 Electrodes) AHA, clip type | NA | NIHON KOHDEN CORPORATION |
16 | 04931921854242 | BR-913PA | BR-913PA | Electrode lead, 3 electrodes (AHA) (Snap type), | NA | NIHON KOHDEN CORPORATION |
17 | 04931921852712 | TL-201T | TL-201T | Finger probe Adult, child (20kg or more) Finger | BluPRO® | NIHON KOHDEN CORPORATION |
18 | 04931921128244 | GZ-140P | GZ-140P | Vital Sign Telemeter | NA | NIHON KOHDEN CORPORATION |
19 | 04931921117415 | GZ-130P | GZ-130P | Vital Sign Telemeter | NA | NIHON KOHDEN CORPORATION |
20 | 04931921117392 | GZ-120P | GZ-120P | Vital Sign Telemeter | NA | NIHON KOHDEN CORPORATION |
21 | 04931921115268 | ZR-920P | ZR-920P | Receiver unit for ZS, ZM series | NA | NIHON KOHDEN CORPORATION |
22 | 04931921103906 | ORG-9110A | ORG-9110A | WMTS digital telemetry receiver; L-BAND 1.4 GHz | NA | NIHON KOHDEN CORPORATION |
23 | 04931921103883 | ORG-9100A | ORG-9100A | WMTS digital telemetry receiver; 608 UHF MHz | NA | NIHON KOHDEN CORPORATION |
24 | 04931921019696 | TL-220T | TL-220T-A1 | Multi-site probe Adults, child (3 kg or more) | BluPRO® | NIHON KOHDEN AMERICA, INC. |
25 | 04931921005828 | TL-271T3 | TL-271T3-A24 | SpO2 probe Adults (30 kg or more) Finger or toe, disposable | BluPRO® | NIHON KOHDEN CORPORATION |
26 | 04719872650287 | GA2001Rx | Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY | Guardian Angel™ Rx | AULISA MEDICAL USA, INC. | |
27 | 04719872650201 | GA2000Rx-P | Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY | Guardian Angel™ Rx | AULISA MEDICAL USA, INC. | |
28 | 04719872650195 | GA2000Rx-A | Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY | Guardian Angel™ Rx | AULISA MEDICAL USA, INC. | |
29 | G012SW0028 | SW-0028 | Web application | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
30 | G012SW0027 | SW-0027 | Investigator application for Android | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
31 | G012SW0026 | SW-0026 | Sync application for Android | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
32 | G012SW0025 | SW-0025 | Link application for Android | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
33 | G012MC0015 | MC-0015 | MC-0015 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
34 | G012MC0014 | MC-0014 | MC-0014 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012B MC-0014 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
35 | G012MC0013 | MC-0013 | MC-0013 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
36 | G012MC0012 | MC-0012 | MC-0012 kit containing DIs G012BRCS02, G012BRCD02, BG012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
37 | G012MC0008 | MC-0008 | MC-0008 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
38 | G012MC0007 | MC-0007 | MC-0007 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012B MC-0007 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
39 | G012MC0006 | MC-0006 | MC-0006 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
40 | G012MC0005 | MC-0005 | MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
41 | G012MC0004 | MC-0004 | Discovery Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G01 Discovery Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05, G012MC0009 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
42 | G012MC0003 | MC0003 | Exploratory Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G Exploratory Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRCT01,G012BSPS01, G012BRCA05, G0123MC0009 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
43 | G012MC00022 | MC00022 | Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smar Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smart Charger, BSPS01 Medical Power Supply, BRCA05 Adhesive Applicator, BRCP03 Phone | BioStamp® nPoint | MEDIDATA SOLUTIONS, INC. | |
44 | G012BSPS01 | BSPS01 | Link Hub smart charger power supply | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
45 | G012BRCT01 | BRCT01 | Mobile Application tablet | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
46 | G012BRCS02 | BRCS02 | Wearable sensor patch | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
47 | G012BRCP03 | BRCP03 | Mobile phone application | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
48 | G012BRCP02 | BRCP02 | Mobile application phone | BioStamp® nPoint | MEDIDATA SOLUTIONS, INC. | |
49 | G012BRCP01 | BRCP01 | Mobile application phone | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
50 | G012BRCD02 | BRCD02 | Link Hub Smart Charger | BioStamp® | MEDIDATA SOLUTIONS, INC. |