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 | 05903021560117 | P4BA-AB-UNI | The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhy The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter. | PocketECG IV – Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
2 | 05903021560100 | P3CH-AB-UNI | The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unifi The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the P4BA-AA-UNI or P4BA-AB-UNI batteries used with PocketECG transmitter. | PocketECG IV – Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
3 | 05903021560094 | P4BA-AA-UNI | The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhy The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter. | PocketECG IV – Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
4 | 05903021560087 | P4TR-AB-ADS | The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmi The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AB-ADS is inteded for use in LTE cellular networks. | PocketECG IV – Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
5 | 05903021560070 | P4TR-AA-ADS | The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmi The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AA-ADS is inteded for use in LTE cellular networks. | PocketECG IV – Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
6 | 05903021560063 | Type: PECGH-III | The holster type PECGH-III is an accessory to the PocketECG III - Medicalgorithm The holster type PECGH-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. It is a belt holder for PocketECG transmitters (types PECGT-III or PECGT-IIIV) for indoor use. | PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
7 | 05903021560056 | Type: PECGT-IIIR | The PocketECG CRS transmitter type PECGT-IIIR is a key component of PocketECG CR The PocketECG CRS transmitter type PECGT-IIIR is a key component of PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG CRS transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. The PocketECG CRS is inteded for use in GSM cellular networks. | PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System | MEDICALGORITHMICS S A | |
8 | 05903021560049 | Type: PECGC-III | The battery charger type PECGC-III is an accessory to the PocketECG III - Medica The battery charger type PECGC-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the PECGB-III batteries used with PocketECG transmitter. | PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
9 | 05903021560032 | Type: PECGB-III | The battery type PECGB-III is an accessory to the PocketECG III - Medicalgorithm The battery type PECGB-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter. | PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
10 | 05903021560025 | Type: PECGT-IIIV | The PocketECG transmitter is a key component of the PocketECG III - Medicalgorit The PocketECG transmitter is a key component of the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-IIIV is inteded for use in CDMA cellular networks. | PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
11 | 05903021560018 | Type: PECGT-III | The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmic The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-III is inteded for use in GSM cellular networks. | PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
12 | 05903021560001 | Type: PC Client | The PC Client software is an accessory to the PocketECG III - Medicalgorithmics The PC Client software is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors. | PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System | MEDICALGORITHMICS S A | |
13 | 05415067040046 | DM4500 | DM4500 | Insertable Cardiac Monitor | Jot Dx™ | ST. JUDE MEDICAL, INC. |
14 | 05415067034304 | DM3500A | DM3500A | Implantable Cardiac Monitor Accessories | Confirm Rx™ | ST. JUDE MEDICAL, INC. |
15 | 05415067027405 | APP1001 | APP1001 | Mobile Application | myMerlin™ | ST. JUDE MEDICAL, INC. |
16 | 05415067027399 | APP1000 | APP1000 | Mobile Application | myMerlin™ | ST. JUDE MEDICAL, INC. |
17 | 05415067027320 | DM3500 | DM3500 | Insertable Cardiac Monitor | Confirm Rx™ | ST. JUDE MEDICAL, INC. |
18 | 04538612914423 | CUFJ-M01 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
19 | 04538612914416 | CUFJ-N01 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
20 | 04538612912061 | LC-8026T | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
21 | 04538612912047 | DS-8900 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
22 | 04538612911071 | LW-7080(G) | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
23 | 04538612909924 | CIO-06CRL-A | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
24 | 04538612908354 | DS-7780W | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
25 | 04538612908330 | DS-7700WL | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
26 | 04538612908316 | DS-7780 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
27 | 04538612908293 | DS-7700L | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
28 | 04538612908279 | LW-7080 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
29 | 04538612908248 | LC-7019FT | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
30 | 04538612039669 | CJ-7546 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
31 | 04538612039645 | CJ-7413 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
32 | 04538612039638 | CJ-7411 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
33 | 04538612039621 | CJ-7412 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
34 | 04538612039614 | CJ-7382 | FUKUDA DENSHI | FUKUDA DENSHI CO.,LTD. | ||
35 | 00884838093218 | Avalon Toco MP Transducer | 867248 | The device is intended to be used for monitoring and recording of, and to genera The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates | PHILIPS Avalon Toco MP Transducer | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
36 | 00884838086654 | Masimo O3 Module | 867184 | Masimo O3 Plug-in Module for IntelliVue Patient Monitors to connect the Masimo O Masimo O3 Plug-in Module for IntelliVue Patient Monitors to connect the Masimo O3 Measurement Device (989803203021) | PHILIPS Masimo O3 Module | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
37 | 00884838050099 | 989803192171 | 989803192171 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
38 | 00884838050082 | 989803191321 | 989803191321 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
39 | 00884838050075 | COMFORT CARE CUFF, ADULT XL | M1574XL | Comfort Care Cuff, Adult Long (navy blue w/edge striping). Limb circumference 27 Comfort Care Cuff, Adult Long (navy blue w/edge striping). Limb circumference 27-35cm. Reusable 2-piece cuff with removable bladder. Quantity 1 cuff. | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG |
40 | 00884838050068 | 989803191301 | 989803191301 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
41 | 00884838023901 | 989803171801 | 989803171801 | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG | |
42 | 00884838021556 | 862393 | 862393 | PHILIPS IntelliVue Microstream CO2 Extension | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | |
43 | 00884838020849 | SO2 Optical Module | 989803151591 | SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips. | Philips SO2 Optical Module | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
44 | 00884838013568 | 989803172241 | 989803172241 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
45 | 00884838013544 | ECG Trunk Cable AAMI/IEC | 989803172221 | ECG Trunk Cable. AAMI/IEC. Connects MX4x Series 3-,5- and 6-wire lead sets to 12 ECG Trunk Cable. AAMI/IEC. Connects MX4x Series 3-,5- and 6-wire lead sets to 12-pin ECG socket instruments (used on Bedside Monitors). Trunk Cable Length = 2.7 m (9 ft). Reusable. 1 Sales unit= 1 cable. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |
46 | 00884838013537 | 989803172211 | 989803172211 | NA | PHILIPS MEDICAL SYSTEMS HSG | |
47 | 00884838013483 | CBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE | 989803171971 | MX40 Patient Cable consists of 6-wire ECG lead set with integrated 8-pin SpO2 co MX40 Patient Cable consists of 6-wire ECG lead set with integrated 8-pin SpO2 connector cable. Grabber leads, IEC color coded. Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |
48 | 00884838013476 | CBL ECG 6 LEAD GRABBER, IEC, TELE | 989803171961 | MX40 Patient Cable consists of 6-wire ECG lead set. Grabber leads, IEC color cod MX40 Patient Cable consists of 6-wire ECG lead set. Grabber leads, IEC color coded. Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |
49 | 00884838013469 | CBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE | 989803171951 | MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin SpO2 co MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin SpO2 connector cable. Grabber leads, IEC color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |
50 | 00884838013452 | CBL ECG 5 LEAD GRABBER, IEC, TELE | 989803171931 | MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color cod MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |