| 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 | 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 | 00868795000212 | SCL9000 | SCL9000 | Patient Cable, Metal Connector for SmartMonitor2 | Med-Dyne | MED-DYNE, INC. |
| 2 | 00868795000205 | SCL8000 | SCL8000 | Patient Cable, Plastic Connector for SmartMonitor 2 | Med-Dyne | MED-DYNE, INC. |
| 3 | 00860237000293 | CS-100 | S-CATH M Mapping Interconnect Cable | CIRCA SCIENTIFIC, LLC | ||
| 4 | 00860004773726 | 10052 | Pacing Cable, 6FT, 2mm Shrouded Connector | AtriAmp - Pacing Cable | ATRILITY MEDICAL LLC | |
| 5 | 00860004773719 | 10039 | Pacing Cable, 6FT, Medtronic® Connector | AtriAmp - Pacing Cable | ATRILITY MEDICAL LLC | |
| 6 | 00860004773702 | 10001 | AtriAmp | AtriAmp | ATRILITY MEDICAL LLC | |
| 7 | 00859290006373 | 70321 | 70321 | Truer Medical Temperature Monitoring Interface Cables offer several different in Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipment. | 400 Series Type Monitor Cable, Right Angle | TRUER MEDICAL, INC. |
| 8 | 00859290006366 | 70320 | 70320 | Truer Medical Temperature Monitoring Interface Cables offer several different in Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipment. | HP 400 series type monitor cable | TRUER MEDICAL, INC. |
| 9 | 00853512006745 | 3603 | 3603 | 3 Lead Monitor Cable | Nikomed ECG Cable | NIKOMED USA |
| 10 | 00853512006707 | 3509 | 3509 | Reusable Grounding Pad Cable 10' with a Boston Scientific style connector, Non-R Reusable Grounding Pad Cable 10' with a Boston Scientific style connector, Non-REM/Non Alarm | NIKO-Surg | NIKOMED USA |
| 11 | 00853512006691 | 3508 | 3508 | Reusable Grounding Pad Cable 10' with a Valleylab style connector and center pin Reusable Grounding Pad Cable 10' with a Valleylab style connector and center pin (REM/Alarm) | NIKO-Surg | NIKOMED USA |
| 12 | 00853512006684 | 3407 | 3407 | Reusable Grounding Pad Cable 10' with a Valleylab style connector and no center Reusable Grounding Pad Cable 10' with a Valleylab style connector and no center pin (Non-REM/Non Alarm) | NIKO-Surg | NIKOMED USA |
| 13 | 00853512006677 | 3406 | 3406 | Reusable Grounding Pad Cable 10' with a 4mm shrouded plug connector | NIKO-Surg | NIKOMED USA |
| 14 | 00853512006660 | 3405 | 3405 | Reusable Grounding Pad Cable 10' with a 6mm plug connector | NIKO-Surg | NIKOMED USA |
| 15 | 00851797006429 | ML-0459 | Disposable Dilator KitKit Contains:ML-0444SInsulated Dilator Set, 7, 12, & 15 MM Disposable Dilator KitKit Contains:ML-0444SInsulated Dilator Set, 7, 12, & 15 MM, SterileML-0345Dilator Clip | SeaSpine | TEDAN SURGICAL INNOVATIONS, L.L.C. | |
| 16 | 00851530007584 | AA-LW-250-RCA | AA-LW-250-RCA | Lead Wire, 250-RCA | Avazzia | AVAZZIA INC |
| 17 | 00851530007577 | AA-LW-4P-RCA | AA-LW-4P-RCA | Lead Wire, 4P-RCA | Avazzia | AVAZZIA INC |
| 18 | 00851530007560 | AA-LW-4P-RB-B | AA-LW-4P-RB-B | Lead Wire, 4P Banana | Avazzia | AVAZZIA INC |
| 19 | 00851530007553 | AA-LW-2T-RB | AA-LW-2T-RB | Lead Wire, 2T-RB | Avazzia | AVAZZIA INC |
| 20 | 00851530007546 | AA-LW-2T-250 | AA-LW-2T-250 | Lead Wire, 2T-250 | Avazzia | AVAZZIA INC |
| 21 | 00851530007539 | AA-LW-4P-2T | AA-LW-4P-2T | Lead Wire, 4P-2T | Avazzia | AVAZZIA INC |
| 22 | 00851530007522 | AA-LW-250-130f | AA-LW-250-130f | Adapter, 250-130f | Avazzia | AVAZZIA INC |
| 23 | 00851530007515 | AA-LW-4P-250 | AA-LW-4P-250 | Lead Wire, 4P-250 | Avazzia | AVAZZIA INC |
| 24 | 00851530007508 | AA-LW-4P-250-15K | AA-LW-4P-250-15K | Attenuator, 4P-250f, 15KO | Avazzia | AVAZZIA INC |
| 25 | 00851530007492 | AA-LW-4P-2X-RB | AA-LW-4P-2X-RB | Lead Wire, 4P-2X-RB | Avazzia | AVAZZIA INC |
| 26 | 00851530007485 | AA-LW-4P-250f | AA-LW-4P-250f | Adapter, 4P-250f | Avazzia | AVAZZIA INC |
| 27 | 00851530007478 | AA-LW-4P-RB | AA-LW-4P-RB | Lead Wire, 4P-RB | Avazzia | AVAZZIA INC |
| 28 | 00851530007461 | AA-LW-130-250f | AA-LW-130-250f | Adapter, 130m-250f | Avazzia | AVAZZIA INC |
| 29 | 00851530007454 | AA-LW-130-RB | AA-LW-130-RB | Lead Wire, 130-RB | Avazzia | AVAZZIA INC |
| 30 | 00851530007447 | AA-LW-250-250-15K | AA-LW-250-250-15K | Attenuator, 250-250f-15KO | Avazzia | AVAZZIA INC |
| 31 | 00851530007430 | AA-LW-250-2X-250f | AA-LW-250-2X-250f | Splitter, 250-2X-250 | Avazzia | AVAZZIA INC |
| 32 | 00851530007423 | AA-LW-250-250 | AA-LW-250-250 | Lead Wire, 250-250 | Avazzia | AVAZZIA INC |
| 33 | 00851530007416 | AA-LW-250-RB | AA-LW-250-RB | Lead Wire, 250-RB | Avazzia | AVAZZIA INC |
| 34 | 00850018485029 | Cable | MGCBLSP | Cable, Electrode | EKG Patch™ (Cable) | NULINE SENSORS, LLC |
| 35 | 00850012681113 | HAR-27 | Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging) | Ives EEG Solutions | IVES EEG SOLUTIONS, LLC | |
| 36 | 00850012681106 | HAR-25 | Ives MR Conditional Electrode System Harness, 25 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 25 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging) | Ives EEG Solutions | IVES EEG SOLUTIONS, LLC | |
| 37 | 00850012681090 | HAR-23 | Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging) | Ives EEG Solutions | IVES EEG SOLUTIONS, LLC | |
| 38 | 00850012681083 | HAR-21 | Ives MR Conditional Electrode System Harness, 21 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 21 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging) | Ives EEG Solutions | IVES EEG SOLUTIONS, LLC | |
| 39 | 00850011306505 | 5.38 m | 31-0202-0005 | Flexible cable to connect the High Density Junction Box to the ATLAS Neurophysio Flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. | High Density Tether 5.38 m | NEURALYNX, INC. |
| 40 | 00850011306499 | 31-0602-0033 | ADPT-HD-Y Adapter Cable for use with the ATLAS Neurophysiology System. | ADPT-HD-Y Adapter Cable | NEURALYNX, INC. | |
| 41 | 00850011306475 | 3m | The High Density Tether is a flexible cable to connect the High Density Junction The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System. | High Density Tether 3m | NEURALYNX, INC. | |
| 42 | 00850011306468 | 2m | 31-0202-0003 | The High Density Tether is a flexible cable to connect the High Density Junction The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System. | High Density Tether 2m | NEURALYNX, INC. |
| 43 | 00850011306451 | 1m | 31-0202-0002 | The High Density Tether is a flexible cable to connect the High Density Junction The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System. | High Density Tether 1m | NEURALYNX, INC. |
| 44 | 00850011306444 | -H | 31-0602-0040 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "H" is labeled for connections to electrodes 449-512. | High Density Junction Box - H | NEURALYNX, INC. |
| 45 | 00850011306437 | -G | 31-0602-0039 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "G" is labeled for connections to electrodes 385-448. | High Density Junction Box - G | NEURALYNX, INC. |
| 46 | 00850011306420 | -F | 31-0602-0038 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "F" is labeled for connections to electrodes 321-384. | High Density Junction Box - F | NEURALYNX, INC. |
| 47 | 00850011306413 | -E | 31-0602-0037 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "E" is labeled for connections to electrodes 257-320. | High Density Junction Box - E | NEURALYNX, INC. |
| 48 | 00850011306406 | -D | 31-0602-0036 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "D" is labeled for connections to electrodes 193-256. | High Density Junction Box - D | NEURALYNX, INC. |
| 49 | 00850011306390 | -C | 31-0602-0035 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "C" is labeled for connections to electrodes 129-192. | High Density Junction Box - C | NEURALYNX, INC. |
| 50 | 00850011306383 | -B | 31-0602-0034 | Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "B" is labeled for connections to electrodes 65-128. | High Density Junction Box - B | NEURALYNX, INC. |