| 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 | 04052682036460 | 1.3 | Z073476 | Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed on a PC Platform for communication with the Volumat MC Agilia infusion pump via a USB cable | Vigilant Drug'Lib AGILIA US | FRESENIUS KABI AG |
| 2 | 04052682034121 | 1.2 | Z073476 | Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed on a PC Platform for communication with the Volumat MC Agilia infusion pump via a USB cable | Vigilant Drug'Lib AGILIA US | FRESENIUS KABI AG |
| 3 | 04046964993459 | 8713140U-99 | 8713140U-99 | SPACE STATION ASSET | NA | B. BRAUN MEDICAL INC. |
| 4 | 04046964958335 | 8713145U-99 | 8713145U-99 | SPACECOVER COMFORT - US VERSION ASSET | NA | B. BRAUN MEDICAL INC. |
| 5 | 04046964958311 | 8713131-99 | 8713131-99 | POLE CLAMP - ASSET | Infusomat® | B. BRAUN MEDICAL INC. |
| 6 | 04046964958304 | 8713060U-99 | 8713060U-99 | INFUSOMAT SPACE ACM-KIT, ASSET | Infusomat® | B. BRAUN MEDICAL INC. |
| 7 | 04046964958281 | 8713052U-99 | 8713052U-99 | ASSET, INFUSOMAT SPACE US + STD BATTERY | Infusomat® | B. BRAUN MEDICAL INC. |
| 8 | 04046964958274 | 8713050U-99 | 8713050U-99 | INFUSOMAT SPACE - US VERSION ASSET | Infusomat® | B. BRAUN MEDICAL INC. |
| 9 | 04046964958250 | 8713040U-99 | 8713040U-99 | PERFUSOR SPACE ACM-KIT, ASSET | Perfusor® | B. BRAUN MEDICAL INC. |
| 10 | 04046964958243 | 8713030U-99 | 8713030U-99 | PERFUSOR SPACE - US VERSION ASSET | Perfusor® | B. BRAUN MEDICAL INC. |
| 11 | 04046964958212 | 8710988-99 | 8710988-99 | EXTERNAL BOLUS BUTTON ASSET | NA | B. BRAUN MEDICAL INC. |
| 12 | 04046964958205 | 8710929-99 | 8710929-99 | IV POLE CLAMP ASSET | Infusomat® | B. BRAUN MEDICAL INC. |
| 13 | 04046964958199 | 637-20299 | 637-20299 | VISTA BASIC IFVB ASSET | Vista® | B. BRAUN MEDICAL INC. |
| 14 | 04046964958182 | 637-102-99 | 637-102-99 | VISTA BASIC INFUS PUMP ASSET | Vista® | B. BRAUN MEDICAL INC. |
| 15 | 04046964958175 | 621-200ES99 | 621-200ES99 | OUTLOOK 200 ES, ASSET | Outlook® | B. BRAUN MEDICAL INC. |
| 16 | 04046964958168 | 621-100ES99 | 621-100ES99 | OUTLOOK 100 ES, ASSET | Outlook® | B. BRAUN MEDICAL INC. |
| 17 | 04046964797965 | 8713032U | 8713032U | Perfusor® Space® Syringe Pump, Non-Wireless | Perfusor® | B. BRAUN MEDICAL INC. |
| 18 | 04046964797958 | 8713031U | 8713031U | Perfusor® Space® Syringe Pump, Wireless | Perfusor® | B. BRAUN MEDICAL INC. |
| 19 | 04046964787782 | 8713131 | 8713131 | SPACE POLE CLAMP (Speed Clamp) | Infusomat® | B. BRAUN MEDICAL INC. |
| 20 | 04046964708626 | 8713052U | 8713052U | Infusomat® Space® Large Volume Pump, Non-Wireless | Infusomat® | B. BRAUN MEDICAL INC. |
| 21 | 04046964660887 | 8713051U | 8713051U | Infusomat® Space® Large Volume Pump, Wireless | Infusomat® | B. BRAUN MEDICAL INC. |
| 22 | 04046964361685 | FZ00621HHS | FZ00621HHS | KIT, HANDHELD SCANNER, OUTLOOK ES | Outlook® | B. BRAUN MEDICAL INC. |
| 23 | 04046964360336 | FZ000621NC | FZ000621NC | KIT, OUTLOOK ES, NURSE CALL BOX | Outlook® | B. BRAUN MEDICAL INC. |
| 24 | 04046964353963 | 8713080U-99 | 8713080U-99 | ASSET, PERFUSOR PCA-KIT | Perfusor® | B. BRAUN MEDICAL INC. |
| 25 | 04046964336713 | 621-324ES | 621-324ES | CONVERSION 300ES TO 400ES | Outlook® | B. BRAUN MEDICAL INC. |
| 26 | 04046964336690 | 621-300ESR | 621-300ESR | OUTLOOK 300ES, REFURB | Outlook® | B. BRAUN MEDICAL INC. |
| 27 | 04046964336676 | 621-224ES | 621-224ES | CONVERSION 200ES TO 400ES | Outlook® | B. BRAUN MEDICAL INC. |
| 28 | 04046964336652 | 621-223ES | 621-223ES | CONVERSION 200ES TO 300ES | Outlook® | B. BRAUN MEDICAL INC. |
| 29 | 04046964336638 | 621-200ESR | 621-200ESR | OUTLOOK 200ES, REFURB | Outlook® | B. BRAUN MEDICAL INC. |
| 30 | 04046964336614 | 621-124ES | 621-124ES | CONVERSION 100ES TO 400ES | Outlook® | B. BRAUN MEDICAL INC. |
| 31 | 04046964336591 | 621-123ES | 621-123ES | CONVERSION 100ES TO 300ES | Outlook® | B. BRAUN MEDICAL INC. |
| 32 | 04046964336577 | 621-122ES | 621-122ES | CONVERSION 100ES TO 200ES | Outlook® | B. BRAUN MEDICAL INC. |
| 33 | 04046964336553 | 621-100ESR | 621-100ESR | OUTLOOK 100ES, REFURB | Outlook® | B. BRAUN MEDICAL INC. |
| 34 | 04046964294518 | 363231 | 363231 | 15 drops/mL, priming volume: 22mL, length: 120in, ULTRASITE® | Infusomat® | B. BRAUN MEDICAL INC. |
| 35 | 04046964294273 | 363031 | 363031 | 15 drops/mL, priming volume: 27mL, length: 133in, SafeLine® | Infusomat® | B. BRAUN MEDICAL INC. |
| 36 | 04046964189425 | V9902F | V9902F | 15 drops/mL, free flow protection, Priming volume 24.6mL, length 113in. | Vista® | B. BRAUN MEDICAL INC. |
| 37 | 04046964186554 | 621-400ESR | 621-400ESR | OUTLOOK 400ES, REFURB | Outlook® | B. BRAUN MEDICAL INC. |
| 38 | 04046964186547 | 621-400ES | 621-400ES | Outlook® 400ES Safety Infusion Pump System | Outlook® | B. BRAUN MEDICAL INC. |
| 39 | 04046964186530 | 621-300ES | 621-300ES | Large Volume Infusion Pump System with Outbound Wireless, Drug Library and Barcoding | Outlook® | B. BRAUN MEDICAL INC. |
| 40 | 04046964186523 | 621-200ES | 621-200ES | Large Volume Infusion Pump System with Drug Library and Barcoding | Outlook® | B. BRAUN MEDICAL INC. |
| 41 | 04046964186516 | 621-100ES | 621-100ES | Large Volume Infusion Pump System | Outlook® | B. BRAUN MEDICAL INC. |
| 42 | 04046964186493 | 620-100R | 620-100R | OUTLOOK 100, REFURB | Outlook® | B. BRAUN MEDICAL INC. |
| 43 | 04046964181627 | 352437 | 352437 | Primary Gravity Filtered Set with 2 ULTRASITE® Injection Sites | ULTRASITE® | B. BRAUN MEDICAL INC. |
| 44 | 04046964085673 | 8713112D | 8713112D | POWER SUPPLY SP US III | B.BRAUN | B. BRAUN MEDICAL INC. |
| 45 | 04046963988852 | 637-202 | 637-202 | Vista® Basic Large Volume Infusion Pump | Vista® | B. BRAUN MEDICAL INC. |
| 46 | 04046963915308 | 8713080U | 8713080U | Perfusor® PCA Syringe Pump | Perfusor® | B. BRAUN MEDICAL INC. |
| 47 | 04046963716783 | 8713145U | 8713145U | SPACECOVER COMFORT - US VERSION | B.BRAUN | B. BRAUN MEDICAL INC. |
| 48 | 04046963716776 | 8713142U | 8713142U | SpaceStation with SpaceCom | B.BRAUN | B. BRAUN MEDICAL INC. |
| 49 | 04046963716769 | 8713140U | 8713140U | SpaceStation | B.BRAUN | B. BRAUN MEDICAL INC. |
| 50 | 04046963716752 | 8713050U | 8713050U | Infusomat® Space Infusion System/ Large Volume Pumps | Infusomat® | B. BRAUN MEDICAL INC. |