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 | 00850018485029 | Cable | MGCBLSP | Cable, Electrode | EKG Patchâ„¢ (Cable) | NULINE SENSORS, LLC |
2 | 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 | |
3 | 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 | |
4 | 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 | |
5 | 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 | |
6 | 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. |
7 | 00850011306499 | 31-0602-0033 | ADPT-HD-Y Adapter Cable for use with the ATLAS Neurophysiology System. | ADPT-HD-Y Adapter Cable | NEURALYNX, INC. | |
8 | 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. | |
9 | 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. |
10 | 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. |
11 | 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. |
12 | 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. |
13 | 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. |
14 | 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. |
15 | 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. |
16 | 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. |
17 | 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. |
18 | 00850011306192 | ATLAS Patient Event Marker | Patient Event Marker | The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neuroph The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software. | ATLAS Patient Event Marker | NEURALYNX, INC. |
19 | 00850011214374 | PMI52-00548 | PMI52-00548 | MONOPOLAR CABLE MALE BANANA/MALE BOVIE | ELMED | PROGRESSIVE MEDICAL INSTRUMENTATION INC |
20 | 00850011214312 | PMI52-00546 | PMI52-00546 | BIPOLAR CABLE DUAL BANANA/2 PIN | ELMED | PROGRESSIVE MEDICAL INSTRUMENTATION INC |
21 | 00850011214305 | PMI52-00532 | PMI52-00532 | MONOPOLAR CABLE 10 FEET | ELMED | PROGRESSIVE MEDICAL INSTRUMENTATION INC |
22 | 00850011214251 | PMI5023 | PMI5023 | MONOPOLAR CABLE WITH OLSEN & BOVIE PLUGS | ELMED | PROGRESSIVE MEDICAL INSTRUMENTATION INC |
23 | 00843059122916 | 48755028 | LEAD, EXTENSION BLUE 183 CM / 72 IN | Stryker | TEDAN SURGICAL INNOVATIONS, L.L.C. | |
24 | 00843059122909 | 48755018 | LEAD, CROCODILE CLIP, 122 CM / 48 IN | Stryker | TEDAN SURGICAL INNOVATIONS, L.L.C. | |
25 | 00843059117745 | ZS-0345 | DILATOR CLIP, STERILE, SINGLE USE | Zimmer | TEDAN SURGICAL INNOVATIONS, L.L.C. | |
26 | 00843059113365 | ML-0345 | DILATOR CLIP, STERILE | TSI | TEDAN SURGICAL INNOVATIONS, L.L.C. | |
27 | 00843059113273 | ML-0302 | EXTENSION LEAD WIRE, 4' | TSI | TEDAN SURGICAL INNOVATIONS, L.L.C. | |
28 | 00841823105813 | L-SRL-16BDIN-21 | L-SRL-16BDIN-21 | TECH-ATTACH Connection System Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
29 | 00841823105806 | L-SRL-16BDIN-11 | L-SRL-16BDIN-11 | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
30 | 00841823105790 | L-SRL-16BDIN-10 | L-SRL-16BDIN-10 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
31 | 00841823105783 | L-SRL-16BDIN | L-SRL-16BDIN | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
32 | 00841823105776 | L-SRL-15BDIN-11 | L-SRL-15BDIN-11 | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
33 | 00841823105769 | L-SRL-14BDIN-11 | L-SRL-14BDIN-11 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
34 | 00841823105752 | L-SRL-14BDIN | L-SRL-14BDIN | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
35 | 00841823105745 | L-SRL-13DIN-11 | L-SRL-13DIN-11 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
36 | 00841823105721 | L-SRL-12BDIN-33 | L-SRL-12BDIN-33 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
37 | 00841823105714 | L-SRL-12BDIN-30 | L-SRL-12BDIN-30 | TECH-ATTACH Connection System Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
38 | 00841823105707 | L-SRL-12BDIN-11 | L-SRL-12BDIN-11 | TECH-ATTACH Connection System Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
39 | 00841823105691 | L-SRL-12BDIN | L-SRL-12BDIN | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
40 | 00841823105684 | L-SRL-120DIN | L-SRL-120DIN | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
41 | 00841823105677 | L-SRL-11DIN-11 | L-SRL-11DIN-11 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
42 | 00841823105660 | L-SRL-10DIN-84 | L-SRL-10DIN-84 | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
43 | 00841823105653 | L-SRL-10DIN-33 | L-SRL-10DIN-33 | TECH-ATTACH Connection System Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
44 | 00841823105646 | L-SRL-10DIN-11 | L-SRL-10DIN-11 | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
45 | 00841823105639 | L-SRL-10DIN | L-SRL-10DIN | Lightweight CABRIO Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
46 | 00841823105622 | L-DCL-9DIN | L-DCL-9DIN | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
47 | 00841823105615 | L-DCL-64DDIN | L-DCL-64DDIN | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
48 | 00841823105608 | L-DCL-8DIN-33 | L-DCL-8DIN-33 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
49 | 00841823105592 | L-DCL-8DIN-21 | L-DCL-8DIN-21 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION | |
50 | 00841823105585 | L-DCL-8DIN-20 | L-DCL-8DIN-20 | Lightweight TECH-ATTACH Cable | AD-TECH MEDICAL INSTRUMENT CORPORATION |