| 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 | 00885825017408 | N/A | 33135 | Dual Connect 5 Lead Cable and Lead | N/A | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| 2 | 00885825017392 | N/A | 33145 | Dual Connect Cable | N/A | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| 3 | 00885825017385 | N/A | 33136 | Dual Connect Lead Set | N/A | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| 4 | 00885825017378 | N/A | 33111 | Chest Leads | N/A | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| 5 | 00885825017361 | N/A | 33110 | 10 Lead Cable and Lead Wire System | N/A | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| 6 | 00885825017354 | N/A | 33105 | 5 Lead Cable and Lead Wire System | N/A | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| 7 | 00885672102715 | ATAR-V2 | ATAR-V2 | Reusable Extension Cable | ATAR V2 | OSCOR INC. |
| 8 | 00885672102708 | ATAR-R X2L | ATAR-R X2L | Reusable Extension Cable | ATAR R X2L | OSCOR INC. |
| 9 | 00885672102692 | ATAR-R X2 | ATAR-R X2 | Reusable Extension Cable | ATAR R X2 | OSCOR INC. |
| 10 | 00885672102685 | ATAR-R T4P | ATAR-R T4P | Reusable Extension Cable | ATAR R T4P | OSCOR INC. |
| 11 | 00885672102678 | ATAR-R T2P | ATAR-R T2P | Reusable Extension Cable | ATAR R T2P | OSCOR INC. |
| 12 | 00885672102661 | ATAR-R D2P | ATAR-R D2P | Reusable Extension Cable | ATAR R D2P | OSCOR INC. |
| 13 | 00885672102654 | ATAR-R1 | ATAR-R1 | Reusable Extension Cable | ATAR R1 | OSCOR INC. |
| 14 | 00885672102647 | ATAR-T2 | ATAR-T2 | Reusable Extension Cable | ATAR T2 | OSCOR INC. |
| 15 | 00885672102630 | ATAR-MDTR | ATAR-MDTR | Reusable Extension Cable | ATAR MDTR | OSCOR INC. |
| 16 | 00885672102623 | ATAR-MDT3 | ATAR-MDT3 | Reusable Extension Cable | ATAR MDT3 | OSCOR INC. |
| 17 | 00885672102616 | ATAR-MDT2 | ATAR-MDT2 | Reusable Extension Cable | ATAR MDT2 | OSCOR INC. |
| 18 | 00885672102609 | ATAR D-IS1-R | ATAR D-IS1-R | Disposable Extension Cable | ATAR D-IS1-R | OSCOR INC. |
| 19 | 00885672102074 | ATAR D-IS1-2Pace | ATAR D-IS1-2Pace | Disposable Extension Cable | ATAR D-IS1 2Pace | OSCOR INC. |
| 20 | 00885672101930 | ATAR-MDTS | ATAR-MDTS | Reusable Extension Cable | ATAR MDTS | OSCOR INC. |
| 21 | 00885672004491 | ATAR-MDT2S-V | ATAR-MDT2S-V | Reusable Extension Cable | ATAR-MDT2S-V | OSCOR INC. |
| 22 | 00885672004484 | ATAR-MDT2S-A | ATAR-MDT2S-A | Reusable Extension Cable | ATAR-MDT2S-A | OSCOR INC. |
| 23 | 00884838021372 | CBL 5 Leadset, Grabber, AAMI, ICU | 989803125841 | 5 Leadset, Grabber, AAMI, ICU | Na | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 24 | 00884838021341 | CBL 6 Lead Set Snap, AAMI, ICU | 989803145181 | 6 Lead Set Snap, AAMI, ICU | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 25 | 00884838021334 | CBL 6 Lead Set Grabber AAMI, ICU | 989803145161 | Lead Set Grabber AAMI, ICU | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 26 | 00884838021327 | CBL 3 Leadset, Grabber, AAMI, OR | 989803145131 | 3 Leadset, Grabber, AAMI, OR | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 27 | 00884838021310 | CBL 3 Leadset, Snap, AAMI, ICU | 989803145111 | 3 Leadset, Snap, AAMI, ICU | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 28 | 00884838075290 | EEG Trunk Cable 2.7 meter | 989803106091 | EEG Trunk Cable 2.7 meter | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 29 | 00884838055476 | 989803192251 | 989803192251 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 30 | 00884838055452 | 989803192231 | 989803192231 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 31 | 00884838055421 | 989803192201 | 989803192201 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 32 | 00884838055414 | 989803192191 | 989803192191 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 33 | 00884838055407 | 989803192181 | 989803192181 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 34 | 00884838037939 | EEG CBL Lead Set Mini for 9 Elec. | 989803180531 | EEG Lead Set with 9 individual color coded leads for use on neonatal and pediatr EEG Lead Set with 9 individual color coded leads for use on neonatal and pediatric patients. Lead wires comes with DIN connector on one end and hard mounted EEG silver clip electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver clip diameter = 6 mm, 80 cm (31.5 in) long leads. Use with trunk cable 989803180541and conductive paste M1937A. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 35 | 00884838037922 | EEG CBL 4CH Trunk Cable, 2.7m | 989803180541 | EEG Trunk Cable, 4 channel, reusable, 2, 7 meter (8.8 ft) long, shielded for 9 l EEG Trunk Cable, 4 channel, reusable, 2, 7 meter (8.8 ft) long, shielded for 9 lead EEG monitoring. Use with 98980310561, 989803180521 or 989803180531 lead sets. The 4 channel trunk cable can also be used for 2 channels. In this case lead sets M1931A, M1932A, M1934A are recommended. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 36 | 00884838037915 | EEG CBL Lead Set Neo/Pedi for 9 Elec. | 989803180521 | EEG Lead Set with 9 individual color coded leads. Lead wires come with DIN conne EEG Lead Set with 9 individual color coded leads. Lead wires come with DIN connector on one end and hard mounted mini cup (grabber style) to connect to any generic snap style electrode on the other end. Wires are hold in place with a lead organizer. 80 cm (31.5 in) long leads.Use with trunk cable 989803180541. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 37 | 00884838037908 | EEG CBL Lead Set Adult for 9 Elec. | 989803180561 | EEG Lead Set with 9 individual color coded leads for use on adults. Lead wires c EEG Lead Set with 9 individual color coded leads for use on adults. Lead wires come with DIN connector on one end and hard mounted EEG silver cup electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver cup diameter = 10mm, 80 cm (31.5 in) long leads.Use with trunk cable 989803180541 and conductive paste M1937A. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 38 | 00884838028326 | 989803176181 | 989803176181 | ECG Lead Set | PHILIPS MEDICAL SYSTEMS HSG | |
| 39 | 00884838028319 | 989803176171 | 989803176171 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 40 | 00884838028302 | 989803176161 | 989803176161 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
| 41 | 00884838021402 | CBL 5 Leadset, Grabber, Chest, AAMI, OR | 989803125901 | 5 Leadset, Grabber, Chest | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 42 | 00884838021396 | CBL 5 Leadset, Grabber,Chest, AAMI,ICU | 989803125881 | 5 Leadset, Grabber, Chest | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 43 | 00884838021389 | CBL 5 Leadset, Grabber, AAMI, OR | 989803125861 | 5 Leadset, Grabber, AAMI, OR | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 44 | 00884838021303 | CBL 3 Leadset, Grabber, AAMI, ICU | 989803145091 | 3 Leadset, Grabber, AAMI, ICU | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 45 | 00884838021297 | CBL Unsh. 5-ld Miniclip AAMI 0.7/1.3m | 989803145011 | Unshielded 5 Lead Miniclip AAMI 0.7/1.3m | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 46 | 00884838021280 | CBL 5 Leadset, Snap, AAMI, ICU | 989803144991 | 5 Leadset, Snap, AAMI, ICU | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 47 | 00884838021273 | CBL Unshielded 3 Ld Miniclip AAMI 0.7m | 989803144941 | Unshielded 3 Lead Miniclip AAMI 0.7m | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 48 | 00884838021266 | 989803144931 | 989803144931 | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | |
| 49 | 00884838021259 | CBL 5 Lead Snap Chest AAMI, ICU | 989803144911 | 5 Lead Snap Chest AAMI, ICU | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
| 50 | 00884838021242 | 989803144881 | 989803144881 | Cable, Electrode | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |