| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04931921899373 | YP-712T | YP-712T | Child Cuff - S951C | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 2 | 04931921899366 | YP-711T | YP-711T | Small Child Cuff - S951B | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 3 | 04931921899359 | YP-710T | YP-710T | Infant Cuff - S951A | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 4 | 14931921902544 | YG-272TW | YG-272TW | cap-One mask, adult | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | cap-ONE | |
| 5 | 14931921902537 | YG-272T | cap-ONE mask, adult | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | cap-ONE | ||
| 6 | 14931921882648 | YP-817P | YP-817P | Disposable cuff for thigh | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | NA | |
| 7 | 04931921898413 | JL-930P | SpO2 connection cord (for Nihon Kohden TL-535U SpO2 probe) | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA | |
| 8 | 04931921840252 | YN-900P | YN-900P | Air hose for adult / child | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 9 | 04931921840238 | TG-900P | TG-900P | CO2 Sensor Kit, Standard | MHX,CCK | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),ANALYZER, G MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | NA |
| 10 | 04931921830451 | NE-311A | NE-311A | EEG Ear Clip Electrode | OLV,GWQ,OLT | Standard polysomnograph with electroencephalograph,Full-montage Standard Electro Standard polysomnograph with electroencephalograph,Full-montage Standard Electroencephalograph,Non-normalizing quantitative electroencephalograph software | 2 | NA |
| 11 | 04931921819142 | NE-134A | NE-134A | EEG collodian electrode set, DIN | OLT,GWQ,OLV,IKN,GWF | Non-normalizing quantitative electroencephalograph software,Full-montage Standar Non-normalizing quantitative electroencephalograph software,Full-montage Standard Electroencephalograph,Standard polysomnograph with electroencephalograph,Electromyograph, diagnostic,STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 12 | 04931921130599 | JW-120A | Event/DC Junction cable for WEE-1200 | GWQ,OLV | Full-montage Standard Electroencephalograph,Standard polysomnograph with electro Full-montage Standard Electroencephalograph,Standard polysomnograph with electroencephalograph | 2 | NA | |
| 13 | 04931921130469 | MU-120A | MU-120A | Main unit for WEE-1200 | OLV,GWQ | Standard polysomnograph with electroencephalograph,Full-montage Standard Electro Standard polysomnograph with electroencephalograph,Full-montage Standard Electroencephalograph | 2 | aireeg |
| 14 | 04931921130445 | ZB-120A | ZB-120A | Telemetry unit for WEE-1200, 64ch | GWQ,OLV | Full-montage Standard Electroencephalograph,Standard polysomnograph with electro Full-montage Standard Electroencephalograph,Standard polysomnograph with electroencephalograph | 2 | aireeg |
| 15 | 04931921130421 | ZB-120A | ZB-120A | Telemetry unit for WEE-1200, 32ch | GWQ,OLV | Full-montage Standard Electroencephalograph,Standard polysomnograph with electro Full-montage Standard Electroencephalograph,Standard polysomnograph with electroencephalograph | 2 | aireeg |
| 16 | 04931921130391 | KC-120A | Cart | OLV,GWQ | Standard polysomnograph with electroencephalograph,Full-montage Standard Electro Standard polysomnograph with electroencephalograph,Full-montage Standard Electroencephalograph | 2 | NA | |
| 17 | 04931921130384 | DH-120A | Holder | GWQ,OLV | Full-montage Standard Electroencephalograph,Standard polysomnograph with electro Full-montage Standard Electroencephalograph,Standard polysomnograph with electroencephalograph | 2 | NA | |
| 18 | 04931921130377 | JW-125A | DC isolation cable for WEE-1200 | OLV,GWQ | Standard polysomnograph with electroencephalograph,Full-montage Standard Electro Standard polysomnograph with electroencephalograph,Full-montage Standard Electroencephalograph | 2 | NA | |
| 19 | 04931921130216 | JB-316B | Amp unit, 16 ch., MEE-2000 | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA | |
| 20 | 14931921882624 | YP-816P | YP-816P | Disposable cuff for adults, extra large | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | NA | |
| 21 | 14931921882600 | YP-815P | YP-815P | Disposable cuff for adults, large | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | NA | |
| 22 | 04931921130162 | QI-170P | QI-170PA | Wireless LAN station | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 23 | 04931921118092 | JS-202B | JS-202B | STIMULATION BOX B, MEE-2000 | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 24 | 14931921882587 | YP-814P | YP-814P | Disposable cuff for adults, medium large | DRG,MHX | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIO TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | NA | |
| 25 | 04931921118085 | JS-201B | JS-201B | STIMULATION BOX A, MEE-2000 | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 26 | 04931921100653 | JE-207A | JE-207A | Electrode junction box (64) | OLT,OLV | Non-normalizing quantitative electroencephalograph software,Standard polysomnogr Non-normalizing quantitative electroencephalograph software,Standard polysomnograph with electroencephalograph | 2 | NA |
| 27 | 04931921130360 | SB-120A | Battery Pack Extension Unit | OLV,GWQ | Standard polysomnograph with electroencephalograph,Full-montage Standard Electro Standard polysomnograph with electroencephalograph,Full-montage Standard Electroencephalograph | 2 | NA | |
| 28 | 04931921118078 | JB-232B | JB-232B | AMP UNIT, 32 CH., MEE-2000 - G1 | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 29 | 14931921882563 | YP-813P | YP-813P | Disposable cuff for adults, standard | DRG,MHX | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIO TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | NA | |
| 30 | 14931921882549 | YP-811P | YP-811P | Disposable cuff for children | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | NA | |
| 31 | 04931921118061 | JB-210B | JB-210B | BREAKOUT BOX, MEE-2000 | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 32 | 14931921881269 | YP-812P | YP-812P | Disposable cuff for adults, small | DRG,MHX | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIO TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | NA | |
| 33 | 04931921114506 | YJ-672P | YJ-672P | ALARM CABLE FOR BSM-6000 | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 34 | 04931921114445 | SC-611R | SC-611RA | POWER SUPPLY KIT FOR WS-960P | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 35 | 04931921114407 | RY-910PA | RY-910PA | Remote Controller | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 36 | 04931921107485 | QD-120A | QD-120A | Analog output unit | OLT | Non-normalizing quantitative electroencephalograph software | 2 | NA |
| 37 | 14931921881245 | YP-810P | YP-810P | Disposable cuff for infants | DRG,MHX | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIO TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | NA | |
| 38 | 04931921107461 | RY-230B | RY-230B | Somato Control Box, MEB-2300 | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 39 | 14931921838195 | YG-101T | YG-101T | Airway adapter for TG-900P | MHX,CCK | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),ANALYZER, G MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | NA | |
| 40 | 04931921902486 | YN-924P | Air hose S for neonates (SnapQuik® connector), 1.5m | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA | |
| 41 | 04931921902332 | BR-946PA | BR-946PA | Electrode lead 6, snap, AHA | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | 2 | NA |
| 42 | 04931921902318 | BR-943PA | BR-943PA | Electrode lead 3, snap, AHA | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | 2 | NA |
| 43 | 04931921902295 | BR-936PA | BR-936PA | Electrode lead 6, clip, AHA | MHX,DRG | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | 2 | NA |
| 44 | 04931921902271 | BR-933PA | BR-933PA | Electrode lead 3, clip, AHA | DRG,MHX | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIO TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 45 | 04931921900970 | BM-122B | BM-122B | tcMEP Stimulation Cable, 10m | GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 2 | NA |
| 46 | 04931921900925 | JL-570T | JL-570T | SpO2 adapter | GWQ,OLV | Full-montage Standard Electroencephalograph,Standard polysomnograph with electro Full-montage Standard Electroencephalograph,Standard polysomnograph with electroencephalograph | 2 | NA |
| 47 | 04931921899601 | SB-920P | SB-920P | Battery Pack, G9 | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 48 | 04931921899595 | SB-170P | SB-170P | BATTERY PACK FOR BSM-1700 | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 49 | 04931921899403 | YP-715T | YP-715T | Thigh Cuff - S951F | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| 50 | 04931921899397 | YP-714T | YP-714T | Large Adult Cuff - S951E | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | NA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00869732000142 | App for Web | This is an application intended to be used by neurologists who are monitoring or This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst. | Persyst Mobile App | PERSYST DEVELOPMENT CORP | |
| 2 | 00869732000135 | App for iOS | This is an application intended to be used by neurologists who are monitoring or This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst. | Persyst Mobile App | PERSYST DEVELOPMENT CORP | |
| 3 | 00869732000128 | P14 | Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring andtrending of EEG recordings during acquisition and reviewing of processed recordings. | Persyst 14 Review and Analysis Software | PERSYST DEVELOPMENT CORP | |
| 4 | 00869732000111 | P13 | Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. | Persyst 13 EEG Review and Analysis Software | PERSYST DEVELOPMENT CORP | |
| 5 | 00869732000104 | P12 | Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. | Persyst 12 EEG Review and Analysis Software | PERSYST DEVELOPMENT CORP | |
| 6 | 00868772000181 | InTouch Lite 4 | InTouch Health | INTOUCH TECHNOLOGIES, INC. | ||
| 7 | 00868772000150 | Lite Remote Presence System V2 | InTouch Health | INTOUCH TECHNOLOGIES, INC. | ||
| 8 | 00868772000143 | Lite Remote Presence System V3 | 20-13333 | InTouch Health | INTOUCH TECHNOLOGIES, INC. | |
| 9 | 00868772000136 | Xpress Remote Presence System Version 2 | 20-14393 | InTouch Health | INTOUCH TECHNOLOGIES, INC. | |
| 10 | 00868772000112 | Vantage Remote Presence System | InTouch Health | INTOUCH TECHNOLOGIES, INC. | ||
| 11 | 00868772000105 | Vita Remote Presence System | 20-15973 | InTouch Health | INTOUCH TECHNOLOGIES, INC. | |
| 12 | 00867975000288 | BWMini PSG | PV 2311 | BWMini PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 13 | 00867975000288 | BWMini PSG | PV 2311 | BWMini PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 14 | 00867975000271 | BWMini HST | PV 2312 | BWMini HST: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 15 | 00867975000271 | BWMini HST | PV 2312 | BWMini HST: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 16 | 00867975000264 | BWMini EEG | PV 2310 | BWMini EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 17 | 00867975000264 | BWMini EEG | PV 2310 | BWMini EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 18 | 00867975000257 | BWII PSG Digital | PV 1825 | BWII PSG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 19 | 00867975000257 | BWII PSG Digital | PV 1825 | BWII PSG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 20 | 00867975000240 | BWII EEG Digital | PV 1652 | BWII EEG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 21 | 00867975000240 | BWII EEG Digital | PV 1652 | BWII EEG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 22 | 00867975000233 | BWIII EEG | PV 2006 | BWIII EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 23 | 00867975000233 | BWIII EEG | PV 2006 | BWIII EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 24 | 00867975000226 | BWIII PSG | PV 2008 | BWIII PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 25 | 00867975000226 | BWIII PSG | PV 2008 | BWIII PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 26 | 00867975000219 | BWIII EEG Plus | PV 2007 | BWIII EEG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 27 | 00867975000219 | BWIII EEG Plus | PV 2007 | BWIII EEG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 28 | 00867975000202 | BWIII PSG Plus | PV 2009 | BWIII PSG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 29 | 00867975000202 | BWIII PSG Plus | PV 2009 | BWIII PSG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
| 30 | 00867606000304 | EVO-002-400-000 | The eVox System is intended for the acquisition, display, and storage, of electr The eVox System is intended for the acquisition, display, and storage, of electrical activityof a patient’s brain including electroencephalograph (EEG) and event-related potentials(ERP) obtained by placing two or more electrodes on the head to aid in diagnosisThe medical system includes the “eVox System” amplifier device, accessories, and acomputer (laptop computer or tablet device with internal battery and power cord).The hardware and ancillary components used in conjunction with the eVox System includean EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, andwall adapter), a Subject Response Device and a Base Station laptop computer. Thesoftware on the Base Station laptop computer is intended for device functioning | eVox System | EVOKE NEUROSCIENCE, INC. | |
| 31 | 00865064000157 | VV330 | VV330 Continuous ECG Platform is a wireless recording system intended for use by VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older. | Continuous ECG Platform | VIVALNK, INC. | |
| 32 | 00863353000307 | 3.0 | Healthcare Access Terminal | BL HEALTHCARE, INC. | ||
| 33 | 00863003000336 | MCGSN 100 Series | EEG Electrode Array | MicroCel Geodesic Sensor Net | ELECTRICAL GEODESICS, INC. | |
| 34 | 00863003000329 | HCGSN 130 | EEG Electrode Array | HydroCel Geodesic Sensor Net | ELECTRICAL GEODESICS, INC. | |
| 35 | 00863003000312 | GPS 3.0 | Full-montage Standard ElectroencephalographCAMERA, SURGICAL AND ACCESSORIES | Geodesic Photogrammetry System | ELECTRICAL GEODESICS, INC. | |
| 36 | 00863003000305 | GES 400 Series | Electroencephalograph | Geodesic EEG System | ELECTRICAL GEODESICS, INC. | |
| 37 | 00862887000371 | PM700 | TelePatch CM PM700 is a small, auto triggered, or patient activated, device, pre TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. | TelePatch Cardiac Monitor | MEDICOMP, INC. | |
| 38 | 00862887000357 | PM500 | Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. | Cardiac Monitor | MEDICOMP, INC. | |
| 39 | 00862186000386 | Rosetta-Lt Data Translator | 040-184-7100 | The Rosetta-Lt Data Translator receives and communicates information from monito The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems. | GD | GENERAL DEVICES |
| 40 | 00862186000379 | CAREpoint Workstation | 040-183-4000 | The CAREpoint Workstation communication console is a standard radio/telephony co The CAREpoint Workstation communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes. | GD | GENERAL DEVICES |
| 41 | 00860508000311 | Version 3.0 Released 20160615 | The Sanitas™ Clinical Care Platform is a software system that collects patient p The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments. The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. | Sanitas™ Clinical Care Platform | SANITAS, INC. | |
| 42 | 00860508000304 | Version 2.0 Released 20160615 | Family Healthware™ is a self-administered, interactive Web-based software tool t Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:+ Health behaviors (e.g., smoking and exercise);+ Screening tests (e.g., blood cholesterol and mammography);+ Health history among his or her first- and second-degree relatives.One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages.The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders. | Family Healthware™ | SANITAS, INC. | |
| 43 | 00860004541707 | SA-002 | ANNE One is a wireless vital signs and physiological data monitoring platform th ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements. | ANNE™ One | SIBEL INC. | |
| 44 | 00860000825818 | InTouch Lite 4 with Boom | InTouch Health | INTOUCH TECHNOLOGIES, INC. | ||
| 45 | 00857175006012 | V100705 | Vectraplex Central Monitoring System | Vectraplex CMS | VECTRACOR INC | |
| 46 | 00856298006305 | TeleRehab Rack Server | 100666 | TeleRehab Rack Server | SCOTTCARE CORPORATION, THE | |
| 47 | 00856298006299 | TeleRehab Receiver Card | 100007 | RF Receiver card to be used in the TeleRehab Receiver Box to receive RF data tra RF Receiver card to be used in the TeleRehab Receiver Box to receive RF data transmission from transmitters. | TeleRehab Receiver Card | SCOTTCARE CORPORATION, THE |
| 48 | 00856298006282 | TR620 | 101127 | The housing used to enclose RF receiver cards for use with the TeleRehab system. | TeleRehab Receiver Box | SCOTTCARE CORPORATION, THE |
| 49 | 00856298006275 | TeleRehab Computer | 101819 | Computer workstation used in conjunction with TeleRehab software. | TeleRehab Computer | SCOTTCARE CORPORATION, THE |
| 50 | 00856298006251 | TeleRehab Software Work Station/Seat License | 101608 | The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow m The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring andrecording of electrocardiograph (ECG) rhythm strips and related information for patients undergoingan exercise therapy program. Patients are monitored by medical telemetry exercise monitoringequipment. This feature allows patients to comply with exercise prescriptions while exercising at amedical/rehabilitation facility near their home, or by returning to the primary medical facility toparticipate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a ProgramManagement module that prints a variety of reports. | TeleRehab Software Work Station/Seat License | SCOTTCARE CORPORATION, THE |