No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00763000500993 | BB11N31R1 | CUSTOM PACK BB11N31R1 RESEARCH PACK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
2 | 00763000500979 | BB11N23R | CUSTOM PACK BB11N23R 10PK XTRASUC | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
3 | 00763000500962 | BB10R11R5 | CUSTOM PACK BB10R11R5 PUMP PK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
4 | 00763000500948 | BB5Z34R5 | CUSTOM PACK BB5Z34R5 NURSES | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
5 | 00763000500931 | BB11G46R1 | CUSTOM PACK BB11G46R1 RQST2 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
6 | 00763000500634 | 7H97R2 | CUSTOM PACK 7H97R2 25PK FEMALE ADAPT | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
7 | 00763000500559 | HY10Z01R8 | CUSTOM PACK HY10Z01R8 SUPPORT PACK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
8 | 00763000501105 | BB5B82R2 | CUSTOM PACK BB5B82R2 5PK SUPPLE 2 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
9 | 00763000511555 | ONYXNG35012UX | STENT ONYXNG35012UX ONYX 3.50X12RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
10 | 00763000498535 | BB11L44R2 | CUSTOM PACK BB11L44R2 OPEN HEART | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
11 | 00763000511470 | ONYXNG30015UX | STENT ONYXNG30015UX ONYX 3.00X15RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
12 | 00763000511418 | ONYXNG27526UX | STENT ONYXNG27526UX ONYX 2.75X26RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
13 | 00763000511326 | ONYXNG25026UX | STENT ONYXNG25026UX ONYX 2.50X26RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
14 | 00763000489472 | HY7Y30R18 | CUSTOM PACK HY7Y30R18 EC AMBU | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
15 | 00763000489434 | BB7L75R3 | CUSTOM PACK BB7L75R3 10PK 3/8X 72 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
16 | 00763000426422 | B3301533M | LEAD B3301533M SENSIGHT 1.5MM EMAN LJ53 | MHY,MRU,NHL,PJS,MBX | Stimulator, electrical, implanted, for parkinsonian tremor,implanted subcortical Stimulator, electrical, implanted, for parkinsonian tremor,implanted subcortical electrical Stimulator (motor disorders),Stimulator, electrical, implanted, for parkinsonian symptoms,Stimulator, electrical, implanted, for essential tremor,Stimulator, thalamic, epilepsy, implanted | 3 | SenSight™ | |
17 | 00763000426408 | B3300542M | LEAD B3300542M SENSIGHT 0.5MM EMAN LJ53 | MBX,NHL,MRU,PJS,MHY | Stimulator, thalamic, epilepsy, implanted,Stimulator, electrical, implanted, for Stimulator, thalamic, epilepsy, implanted,Stimulator, electrical, implanted, for parkinsonian symptoms,implanted subcortical electrical Stimulator (motor disorders),Stimulator, electrical, implanted, for essential tremor,Stimulator, electrical, implanted, for parkinsonian tremor | 3 | SenSight™ | |
18 | 00763000334178 | 11D35R | CUSTOM PACK 11D35R RETO5 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
19 | 00763000334130 | 11D33R | CUSTOM PACK 11D33R RETO1 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
20 | 00763000306144 | ETBF3216C166E | STENT GRAFT ETBF3216C166E ENDUR II BIF | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
21 | 00763000305659 | ETLW1624C93E | STENT GRAFT ETLW1624C93E ENDUR II LIMB | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
22 | 00763000305598 | ETLW1620C82E | STENT GRAFT ETLW1620C82E ENDUR II LIMB | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
23 | 00763000271220 | 7800RR36 | RING 7800RR36 SIMUFORM SR 36MM US | KRH | RING, ANNULOPLASTY | 2 | SimuForm™ | |
24 | 00763000271107 | 7700FR32 | RING 7700FR32 SIMUPLUS FLEX 32MM US | KRH | RING, ANNULOPLASTY | 2 | SimuPlus™ | |
25 | 00763000499945 | BB5U74R18 | CUSTOM PACK BB5U74R18 TUBING | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
26 | 00763000499921 | BB8S37R29 | CUSTOM PACK BB8S37R29 PUMP TBL | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
27 | 00763000511647 | ONYXNG40012UX | STENT ONYXNG40012UX ONYX 4.00X12RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
28 | 00763000498870 | CB11N89R | CUSTOM PACK CB11N89R MAN/BRIDGE | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
29 | 00763000260743 | VNMC2828C90TU | STENT GRAFT VNMC2828C90TU VAL NAV CS | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Valiant Navion™ | |
30 | 00763000001377 | BB8B73R7 | CUSTOM PACK BB8B73R7 PK | DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS | 2 | NA | |
31 | 00681490024273 | 05328 | CABLE 05328 ATAKR EGM SAFETY 8FT | LPB | Cardiac ablation percutaneous catheter | 3 | NA | |
32 | 00673978549071 | 5344 | PLUG 5344 1/4 INCH | DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS | 2 | NA | |
33 | 00643169796454 | AB9U20100090 | STENT AB9U20100090 ABRE V01 | QAN | Stent, iliac vein | 3 | Abre™ | |
34 | 00643169518919 | 97740 | PROG 97740 PATIENT MRICS SCS USA ROHS | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA | |
35 | 00643169078024 | 500FA27 | MHV 500FA27 STD AORTIC | LWQ | HEART-VALVE, MECHANICAL | 3 | Open Pivot™ | |
36 | 00613994759221 | 680R32 | RING 680R32 PROFILE 3D 26L MEXICO | KRH | RING, ANNULOPLASTY | 2 | PROFILE 3D® | |
37 | 00613994691392 | 37642 | PRGMR 37642 PATIENT DBS W SC,PC,RC | MFR,NHL,MHY,OLM,MRU | Stimulator, brain, implanted, for behavior modification,STIMULATOR, ELECTRICAL, Stimulator, brain, implanted, for behavior modification,STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS,STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR,Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcortical electrical Stimulator (motor disorders) | 3 | NA | |
38 | 00613994334565 | 68005YN | CABLE 68005YN EGM 18L | OCL | Surgical Device, For cutting, coagulation, and/or ablation of tissue, including Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue | 2 | NA | |
39 | 00885074469669 | 365538 | TUNNEL TOOL 365538 ACCESSORY KIT US MKT | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA | |
40 | 00885074375458 | SB7MAC30 | CATHETER SB7MAC30 SB 7F 100CM MA30 | DQY | CATHETER, PERCUTANEOUS | 2 | SHERPA NX BALANCED | |
41 | 00885074372181 | SB7EBU40D | CATHETER SB7EBU40D SB 7F 90CM EB40 | DQY | CATHETER, PERCUTANEOUS | 2 | SHERPA NX BALANCED | |
42 | 00763000665982 | BB11V67R3 | CUSTOM PACK BB11V67R3 UMC | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
43 | 00763000552985 | CB11J56R3 | CUSTOM PACK CB11J56R3 PEDI MAG | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
44 | 00763000541118 | 6A32R2 | CUSTOM PACK 6A32R2 1/4X1/4 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
45 | 00763000400866 | 3320L | LIT 3320L DYSTONIA EMANUALS EN | MRU | implanted subcortical electrical Stimulator (motor disorders) | N/A | ||
46 | 00763000502843 | FMET-IM-SYS-S | SYSTEM SERVICED FMET-IM-SYS-S | DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | 2 | FlowMet™ | |
47 | 00763000390891 | LA6ERADRST | CATHETER LA6ERADRST LA 6F 100CM ERDRS | DQY | Catheter, percutaneous | 2 | Launcher | |
48 | 00763000310332 | 37601 | INS 37601 ACTIVA PC DBS EMANUAL EN | OLM,MRU,MHY,NHL,MBX,PJS | Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcorti Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcortical electrical Stimulator (motor disorders),STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR,Stimulator, electrical, implanted, for parkinsonian symptoms,STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED,Stimulator, electrical, implanted, for essential tremor | 3 | Activa® PC | |
49 | 00763000306519 | 104FS | FOOTSWITCH 104FS CRYOCONSOLE MDR | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
50 | 00763000301330 | HC150A | HANDCRANK HC150A PLX 31L | DWA | Control, pump speed, cardiopulmonary bypass | 2 | Affinity™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03760232460184 | V1 | The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177) | BA-HFVI-V1 | MDOLORIS MEDICAL SYSTEMS | |
2 | 03760232460177 | V1 | HFVI Monitor is intended for use in a medical environment and under the direct s HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The system is intended for use on adult and pediatric patients, in a facility providing patient care by monitoring heart rate variability.The High Frequency Variability Index (HFVI) is a complex monitoring technology intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the HFVI in conjunction with other available clinical signs. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate HFVI values. Potential artifacts may be caused by muscle activity or rigidity, patient motion, improper sensor placement or electrical interference. | HFVi monitor | MDOLORIS MEDICAL SYSTEMS | |
3 | 03760165449270 | BW-HR1 | BEWELL CONNECT MyECG | VISIOMED GROUP | ||
4 | 03700546706400 | HWA09 | Withings® | WITHINGS | ||
5 | 03700546706400 | HWA09 | Withings® | WITHINGS | ||
6 | 03615220001156 | 1005-15003-US | 1005-15003-US | Cardioskin Charger | BIOSERENITY | |
7 | 03615220001149 | 1005-15002-US | 1005-15002-US | Cardioskin Battery | BIOSERENITY | |
8 | 03615220001132 | 1005-15001-US | 1005-15001-US | Cardioskin Dock | BIOSERENITY | |
9 | 03615220001125 | 1005-10001-US | 1005-10001-US | Cardioskin Recorder | BIOSERENITY | |
10 | 00884838107199 | TC50 | 860466 | TC50Cardiograph system with Pelican Case | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
11 | 00884838091702 | 453564798921 | 453564798921 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
12 | 00884838091689 | TC50 Government Bundle With Trolley | 860429 | Includes A02 Cardiograph+A0X A Format+D01 All Orders (incl Manual Orders)+D02 AD Includes A02 Cardiograph+A0X A Format+D01 All Orders (incl Manual Orders)+D02 ADT Support+D03 DXL ECG Interpretation+D05 ECG Full disclosure+D06 ECG Archive+D08 DICOM ECG result output+D12 Last ECG InterAct Query+D24 Wireless 802 11+D50 A.07.05 (CE7)+E06 Double Sided Tab Clips+H15 Second Battery+H16 Membrane Keyboard+H21 PIM 12 Lead+H23 Long Lead Wires+W02 Bench Repair+M2481A+13943B 10 packs+860309 B01 Partially Assembled Trolley+C02 Storage Bin+C04 Wire Basket | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
13 | 00884838087293 | 453564659351 | 453564659351 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
14 | 00884838087286 | 453564659341 | 453564659341 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
15 | 00884838087279 | 453564659331 | 453564659331 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
16 | 00884838087262 | 453564659321 | 453564659321 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
17 | 00884838082007 | TC30 government Bundle w trolley | 860354 | PageWriter TC30 government bundle with trolley | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
18 | 00884838081185 | 453564150771 | 453564150771 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
19 | 00884838081178 | 453564150761 | 453564150761 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
20 | 00884838081123 | PageWriter TC30 Cardiograph | 860306 | PageWriter TC30 | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
21 | 00884838081116 | TC70 government bundle without trolley | 860353 | PageWriter TC70 government bundle without trolley | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
22 | 00884838080836 | 453564150751 | 453564150751 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
23 | 00884838080829 | 453564150741 | 453564150741 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
24 | 00884838032545 | TC30 government bundle without trolley | 860355 | PageWriter TC30 government bundle without trolley | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
25 | 00884838032514 | TC70 government Bundle w trolley | 860352 | PageWriter TC70 US Government all-inclusive bundle with trolley Includes A02 Car PageWriter TC70 US Government all-inclusive bundle with trolley Includes A02 Cardiograph+D01 All Orders+D02 ADT Support+D03 DXL ECG Interpretation+D05 ECG Full disclosure+D06 ECG Archive+D08 DICOM ECG result output+D12 Last ECG InterAct Query+D24 Wireless 802 11 abgn SWHW+D50 WIN CE7+E06 Double Sided Tab Clips+H15 Second Battery+H16 Membrane Keyboard+H21 PIM 12 Lead+H23 Long Lead Wires+W01 Onsite Repair+M2481A+13943B 10packs+860318 B01 Partially Assembled Trolley+C02 Storage Bin+C04 Wire Basket | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
26 | 00884838026582 | PageWriter TC70 Cardiograph | 860315 | PageWriter TC70 Cardiograph | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
27 | 00884838026568 | PageWriter TC50 Cardiograph | 860310 | PageWriter TC50 Cardiograph | PageWriter | PHILIPS MEDICAL SYSTEMS HSG |
28 | 00884838016002 | 989803158501 | 989803158501 | CAB,ECG,5 LD,UNSHLD,10FT,SAFTY | INVIVO CORPORATION | |
29 | 00884838012486 | CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC | 989803170181 | OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code sys OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products | ECG Trunk Cable | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
30 | 00884838012479 | 989803170171 | 989803170171 | OR 3-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code sys OR 3-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
31 | 00869770000234 | K100A101X | ZIO SR ECG Monitoring Service | ZIO SR Patch | IRHYTHM TECHNOLOGIES, INC. | |
32 | 00869770000210 | A100A100X | ZIO AT ECG Monitoring Service | ZIO AT Patch | IRHYTHM TECHNOLOGIES, INC. | |
33 | 00868282000220 | RS-10003 | RhythmStar | RHYTHMEDIX, LLC | ||
34 | 00868282000213 | RS-10002V | RhythmStar | RHYTHMEDIX, LLC | ||
35 | 00868282000206 | RS-10002 | RhythmStar | RHYTHMEDIX, LLC | ||
36 | 00865536000234 | 3.1 | A standalone HeRO monitor for two infants | HeRO duet | MEDICAL PREDICTIVE SCIENCE CORPORATION | |
37 | 00865536000227 | 3.1 | A HeRO System for the private room | HeRO solo | MEDICAL PREDICTIVE SCIENCE CORPORATION | |
38 | 00865536000210 | 3.1 | HeRO ES | MEDICAL PREDICTIVE SCIENCE CORPORATION | ||
39 | 00865536000203 | 3.1 | Server based HeRO System | HeRO symphony | MEDICAL PREDICTIVE SCIENCE CORPORATION | |
40 | 00863609000327 | E5 | DUO | EKO DEVICES, INC. | ||
41 | 00862887000364 | PM461 | Decipher Holter Monitor is a small, patient worn device, prescribed by physician Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. | Decipher Holter Monitor | MEDICOMP, INC. | |
42 | 00860004366256 | 3 | physIQ Heart Rhythm and Respiratory Module | physIQ Heart Rhythm and Respiration Module | PHYSIQ, INC | |
43 | 00860003939734 | V2.0 | 790.102.200 | The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm.The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s). | AfibAlert / hom ecg+ | LOHMAN TECHNOLOGIES, LLC |
44 | 00860003939703 | V1.5 | 790.0102.001 | The AfibAlert® is a cardiac event recorder capable of recording and storing ~fiv The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 45-second events in solid-state non-volatile memory. AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.The device can record a single channel of ECG data in four ways: (I) via the two thumb electrodes, (2) by placement on the chest, (3) by applying wrist electrodes or (4) applying two sticky electrodes as instructed by their physician. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF.If AF is indicated, or concerning symptoms are present, the patient can either use a Bluetooth connection to a smart device or use a USB connection to a computer to transfer their ECG data to be viewed and/or shared with their physician. | AfibAlert | LOHMAN TECHNOLOGIES, LLC |
45 | 00860001651911 | 1 | SA7525HHS | The HindexRV® Monitoring System is a physiological monitoring device that collec The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data. | HindexRV | HHS SYSTEMS, INC. |
46 | 00860001651904 | 1 | SA7525HHS | The HindexRV® Monitoring System is a physiological monitoring device that collec The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data. | HindexRV | HHS SYSTEMS, INC. |
47 | 00860000272414 | RX-1 | The Rhythm Express RX-1 will be worn by adult patients for a period of time as p The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network.The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. | Rhythm Express | VIVAQUANT, INC. | |
48 | 00860000272407 | RX-1 mini | The Rhythm Express RX-1 mini will be worn by adult patients for a period of time The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network.The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. | Rhythm Express | VIVAQUANT, INC. | |
49 | 00857553006009 | CS-2020-A | CS-2020-A | CardeaScreen is a portable ECG recorder designed for collection of resting (non- CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data. | CardeaScreen | CARDIAC INSIGHT, INC. |
50 | 00857335005091 | RW2 | 2 component patch RW2 | MyCite Patch | OTSUKA AMERICA PHARMACEUTICAL INC |