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 | B146EZP0 | 32774 | PERISTALTIC INFILTRATION PUMP | EZ Pump | BRAEMAR MANUFACTURING, LLC | |
2 | B101PUMPBG3230 | PUMP-BG323 | BG 323 Pump | CME AMERICA LLC | ||
3 | B101AEG1PUMP0 | AEG-1PUMP | Pump, charger, operations manual | Ameritus Orange NeoFeed Pump System | CME AMERICA LLC | |
4 | B101A150331X0 | A150-331X | Table Top Charger | CME AMERICA LLC | ||
5 | B101190900PXCVP0 | 190-900PXCVP | Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles up to 50 mm in diameter (1), keys (2), Instructions for Use (1). | 500ml Ultimate Lockbox | CME AMERICA LLC | |
6 | B101190900PXCV0 | 190-900PXCV | 500ml Lock Box Kit | CME AMERICA LLC | ||
7 | B101190000XGU0 | 190-000XGU | 500ml Green Lockbox | CME AMERICA LLC | ||
8 | B101151143XLR0 | 151-143XLR | Refurbished Wall Charger | CME AMERICA LLC | ||
9 | B101151143XLP0 | 151-143XLP | Wall Charger, Instructions | Wall Charger | CME AMERICA LLC | |
10 | B101151143XL0 | 151-143XL | Wall Charger | CME AMERICA LLC | ||
11 | B101150386XR0 | 150-386XR | Refurbished CMExpress® Pump Pole Mount Charger | CME AMERICA LLC | ||
12 | B101150386X0 | 150-386X | CMExpress® Pump Pole Mount Charger | CME AMERICA LLC | ||
13 | B101150331XP0 | 150-331XP | Tabletop Charger (1), Standard Power Cord (1) | Table Top Charger | CME AMERICA LLC | |
14 | B101150317TSR0 | 150-317TSR | Refurbished BodyGuard® 121 Pole Mount Charger with DC | CME AMERICA LLC | ||
15 | B101150317TS0 | 150-317TS | BodyGuard® 121 Pole Mount Charger with DC | CME AMERICA LLC | ||
16 | B101150314XUR0 | 150-314XUR | Refurbished BodyGuard® Pole Mount Charger | CME AMERICA LLC | ||
17 | B101150314XUP0 | 150-314XUP | Pole Mount Charger | BodyGuard® Pole Mount Charger Kit | CME AMERICA LLC | |
18 | B101150314XU0 | 150-314XU | BodyGuard® Pole Mount Charger | CME AMERICA LLC | ||
19 | B101150313XVP0 | 150-313XVP | pole mount charger (1), standard power cord (1) | BodyGuard® ColorVision® Pole Mount Charger Kit | CME AMERICA LLC | |
20 | B101150313XVAR0 | 150-313XVAR | Refurbished BodyGuard® Vision Pole Mount Charger | CME AMERICA LLC | ||
21 | B101150313XVA0 | 150-313XVA | BodyGuard® ColorVision® Pole-mount Charger without DC | CME AMERICA LLC | ||
22 | B101150313XU0 | 150-313XU | BodyGuard® Pole Mount Charger | CME AMERICA LLC | ||
23 | B101140300XP0 | 140-300XP | bolus cable (1) | Bolus Button Cable with Light | CME AMERICA LLC | |
24 | B101140300X0 | 140-300X | Bolus Button Cable with Light | CME AMERICA LLC | ||
25 | B101140100X0 | 140-100X | Bolus Button Cable | CME AMERICA LLC | ||
26 | B101140000XP0 | 140-000XP | bolus cable (1) | Bolus Button Cable | CME AMERICA LLC | |
27 | B101140000X0 | 140-000X | Final Connection Bolus Blue | CME AMERICA LLC | ||
28 | B101100919PXIS0 | 100-919PXIS | BodyGuard® infusion pump system 545 | CME AMERICA LLC | ||
29 | B101100908PTSR0 | 100-908PTSR | Refurbished Pump, Pole Mount Charger, Power Cord, Operator's Manual | Refurbished BodyGuard® 121 Twins Pump | CME AMERICA LLC | |
30 | B101100908PTS0 | 100-908PTS | Pump, Pole Mount Charger, Power Cord, Operator's Manual | BodyGuard® 121 Twins Pump | CME AMERICA LLC | |
31 | B101100743XI0 | 100-743XI | BG545 with EPI28A | CME AMERICA LLC | ||
32 | B101100729PXSR0 | 100-729PXSR | Refurbished Pump, Battery 1800mAh, Pole Mount Charger, Power Cord, Operator's Manual | Refurbished BodyGuard® 575 Pump | CME AMERICA LLC | |
33 | B101100729PXS0 | 100-729PXS | Pump, Battery 1800mAh, Pole-Mount Charger, Power Cord, Operator's Manual | BodyGuard® 575 pump | CME AMERICA LLC | |
34 | B101100725XSR0 | 100-725XSR | Refurbished BG575 Pump | CME AMERICA LLC | ||
35 | B101100725XS0 | 100-725XS | BodyGuard® 575 Pump | CME AMERICA LLC | ||
36 | B101100620XCVR0 | 100-620XCVR | Refurbished BodyGuard 575 ColorVision Pump | CME AMERICA LLC | ||
37 | B101100620XCV0 | 100-620XCV | BodyGuard 575 ColorVision Pump | CME AMERICA LLC | ||
38 | B101100615PXCVR0 | 100-615PXCVR | Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual | Refurbished BodyGuard® 575 ColorVision® Pump System | CME AMERICA LLC | |
39 | B101100615PXCV0 | 100-615PXCV | Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual | BodyGuard® 575 ColorVision® Pump System | CME AMERICA LLC | |
40 | B101100610XCVR0 | 100-610XCVR | Refurbished BG 545CV Pump | CME AMERICA LLC | ||
41 | B101100610XCV0 | 100-610XCV | BodyGuard® 545 ColorVision Pump | CME AMERICA LLC | ||
42 | B101100610PXCVR0 | 100-610PXCVR | Refurbished Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Refurbished Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual | Refurbished BodyGuard® 545 ColorVision® Pump System | CME AMERICA LLC | |
43 | B101100610PXCV0 | 100-610PXCV | Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual | BodyGuard® 545 ColorVision® Pump System | CME AMERICA LLC | |
44 | B101100603XSAR0 | 100-603XSAR | Refurbished BG 323 Pump | CME AMERICA LLC | ||
45 | B101100603XSAPR0 | 100-603XSAPR | Refurbished Pump | Refurbished BG 323 Pump | CME AMERICA LLC | |
46 | B101100603XSAP0 | 100-603XSAP | Pump, PCA Bolus IFU | BG 323 Pump | CME AMERICA LLC | |
47 | B101100603XSA0 | 100-603XSA | BG 323 Pump | CME AMERICA LLC | ||
48 | B101100517PXSR0 | 100-517PXSR | Refurbished BG323 Pump, Battery 1800 mAh, Wall Charger, Operator's Manual | Refurbished BG 323 Pump System | CME AMERICA LLC | |
49 | B101100517PXS0 | 100-517PXS | pump, battery 1800mHh, wall charger, Operator's Manual | BG 323 Pump System | CME AMERICA LLC | |
50 | B101100516PXSR0 | 100-516PXSR | Refurbished BG323 Pump, Battery 3600 mAh, Wall Charger, Operator's Manual | Refurbished BG 323 Pump System | CME AMERICA LLC |