CARESCAPE Monitor B650 and CARESCAPE Monitor B850

Cardiovascular Devices

2

No

Nationwide Distribution including DC and PR, except DE, SD, ND, and VT. OUS: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic ,Denmark, Ecuador, Egypt, El Salvador, Estonia ,Finland, France, Germany, Greece,Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Uruguay.

GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. || The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.

Mfg Lot or Serial # SEW13380452HA SEW13380454HA SEW13380455HA SEW13380500HA SEW13380501HA SEW13380502HA SEW13380503HA SEW13380504HA SEW13380505HA SEW13380506HA SEW13380507HA SEW13380508HA SEW13380509HA SEW13380512HA SEW13380520HA SEW13380524HA SEW13380525HA SEW13380526HA SEW13380534HA SEW13380535HA SEW13380536HA SKA13130068GA SKA13130071GA SKA13130075GA SKA13130077GA SKA13130078GA SKA13130082GA SKA13130085GA SKA13140118GA SKA13370167GA SKA13370211GA SKA13370214GA SKA13370215GA SKA13370216GA SKA13370217GA SKA13370218GA SKA13370219GA SKA13370220GA SKA13370221GA SKA13370222GA SKA13370223GA SKA13370224GA SKA13370225GA SKA13370226GA SKA13370227GA SKA13370228GA SKA13370229GA SKA13370230GA SKA13370231GA SKA13370232GA SKA13370233GA SKA13370234GA SKA13370235GA SKA13370236GA SKA13370237GA SKA13370238GA SKA13370239GA SKA13370240GA SKA13370241GA SKA13370242GA SKA13370263GA SKA13370265GA SKA13370267GA SKA13370268GA SKA13370269GA SKA13370270GA SKA13370271GA SKA13370272GA SEW13380133HA SEW13380155HA SEW13380256HA SEW13380258HA SEW13380259HA SEW13380260HA SEW13380264HA SEW13380265HA SEW13380266HA SEW13380267HA SEW13380268HA SEW13380269HA SEW13380271HA SEW13380305HA SEW13380319HA SEW13380371HA SEW13380375HA SEW13380377HA SEW13380400HA SEW13380413HA SEW13380415HA SEW13380422HA SEW13380423HA SEW13380424HA SEW13380425HA SEW13380426HA SEW13380427HA SEW13380429HA SEW13380432HA SEW13380433HA SEW13380434HA SEW13380435HA SEW13380436HA SEW13380437HA SEW13380438HA SEW13380439HA SEW13380440HA SEW13380441HA SEW13380442HA SEW13380443HA SEW13380444HA SEW13380445HA SEW13380446HA SEW13380447HA SEW13380453HA SEW13380459HA SEW13380461HA SEW13380463HA SEW13380464HA SEW13380465HA SEW13380497HA SEW13380498HA SEW13380499HA SKA13130089GA SKA13130101GA                   SED13017065GA SED13017067GA SED13027233GA SED13027251GA SED13027253GA SED13027259GA SED13027261GA SED13027263GA SED13027265GA SED13027266GA SED13027267GA SED13027268GA SED13027269GA SED13027270GA SED13027271GA SED13027272GA SED13027273GA SED13027274GA SED13027275GA SED13027276GA SED13027277GA SED13027278GA SED13027412GA SED13027413GA SED13027415GA SEW13379826HA SEW13379860HA SEW13379863HA SEW13380254HA SEW13380306HA SEW13380313HA SEW13380399HA SEW13380402HA SKA13370170GA    SED10353754GA SED10353755GA SED10353756GA SED10353757GA SED10353758GA SED10353759GA SED10353760GA SED10353761GA SED10373970GA SED10373971GA SED10373972GA SED10373973GA SED10373974GA SED10373975GA SED10373977GA SED10373980GA SED10373981GA SED10373983GA SED10373988GA SED10374003GA SED10384049GA SED10384064GA SED10384085GA SED10384087GA SED10384092GA SED10384100GA SED10384102GA SED10384107GA SED10384109GA SED10384112GA SED10384117GA SED10384119GA SED10384120GA SED10384121GA SED10384122GA SED10384123GA SED10384124GA SED10384125GA SED10384126GA SED10384127GA SED10384128GA SED10384129GA SED10384131GA SED10384132GA SED10384143GA SED10384149GA SED10394174GA SED10404188GA SED10485073GA SED10536439GA SED10536442GA SED10536443GA SED10536444GA SED10536447GA SED10536457GA SED10536459GA SED10536473GA SED11026570GA SED11036588GA SED11036609GA SED11036610GA SED11036618GA SED11036619GA SED11036620GA SED11036622GA SED11036658GA SED11036660GA SED11036662GA SED11036668GA SED11036675GA SED11036686GA SED11057067GA SEW10334205HA SEW10334221HA SEW10334222HA SEW10334244HA SEW10334255HA SEW10385224HA SEW10385242HA SEW10385273HA SEW10385281HA SEW10466987HA SEW10466989HA SEW10466990HA SEW10466991HA SEW10466992HA SEW10466993HA SEW10466995HA SEW10466997HA SEW10466999HA SEW10467002HA SEW10467006HA SEW10467007HA SEW10467087HA SEW10467088HA SEW10467089HA SEW10467092HA SEW10467093HA SEW10467094HA SEW10467096HA SEW10467358HA SEW10467370HA SEW11141062HA SEW11151201HA SEW11151278HA SEW11171443HA SEW11171494HA SEW11171513HA SEW11181832HA SEW11202312HA SEW11202689HA SEW11202691HA SEW13380257HA SEW13380263HA SEW13380275HA SEW13380276HA SEW13380277HA SEW13380286HA SEW13380322HA SEW13380367HA SEW13380368HA SEW13380373HA SEW13380386HA SEW13380387HA SEW13380391HA SEW13380511HA SEW13380514HA SEW13380517HA SEW13380527HA SEW13380528HA SEW13380529HA SEW13380531HA SEW13380533HA SEW13380537HA SEW13380541HA SEW13380542HA SEW13390694HA SEW13390695HA SEW13390696HA SEW13390697HA SEW13390704HA SEW13390710HA SKA13360147GA SKA13360148GA SKA13360149GA SKA13360150GA SKA13360152GA SKA13360156GA SKA13360157GA SKA13360158GA SKA13360159GA SKA13360160GA SKA13360161GA SKA13360162GA SKA13370194GA SKA13370205GA SKA13370206GA SKA13370207GA SKA13370208GA SKA13370210GA SKA13370212GA SKA13370213GA SED11199036GA SED11199040GA SED11209172GA SED11209176GA SED11209177GA SED11209178GA SED11209188GA SED11209213GA SED11209215GA SED11209219GA SED11209221GA SED11209222GA SED11209223GA SED11209225GA SED11209226GA SED11209227GA SED11209228GA SED11209229GA SED11209230GA SED11209231GA SED11219232GA SED11219233GA SED11219234GA SED11219235GA SED11219238GA SED11219239GA SED11219240GA SED11219241GA SED11219242GA SED11219243GA SED11219245GA SED11219246GA SED11219247GA SED11219248GA SED11219249GA SED11219252GA SED11219253GA SED11219254GA SED11219255GA SED11219256GA SED11219258GA SED11219259GA SED11219262GA SED11219263GA SED11219265GA SED11219266GA SED11219267GA SED11219270GA SED11219273GA SED11219279GA SED11219280GA SED11219281GA SED11219282GA SED11219284GA SED11219299GA SED11219300GA SED11219302GA SED11219303GA SED11219304GA SED11219305GA SED11219306GA SED11219307GA SED11219308GA SED11219309GA SED11219310GA SED11219311GA SED11219312GA SED11219313GA SED11219314GA SED11219315GA SED11219317GA SED11219318GA SED11219319GA SED11219320GA SED11219321GA SED11219322GA SED11219325GA SED11219326GA SED11219327GA SED11219328GA SED11219330GA SED11219339GA SED11219343GA SED11219387GA SED11219388GA SED11219403GA SEW11140794HA SEW11140799HA SEW11140801HA SEW11140805HA SEW11140808HA SEW11140878HA SEW11140990HA SEW11141000HA SEW11141013HA SEW11141016HA SEW11202251HA SEW11202256HA SEW11202257HA SEW11202259HA SEW11202265HA SEW11202269HA SEW11202270HA SEW11202272HA SEW11202273HA SEW11223135HA SEW11405474HA SEW11405475HA SEW11405515HA SEW11405517HA SEW11405518HA SEW11405519HA SEW11405520HA SEW11405522HA SEW11405526HA SEW11405527HA SEW11405528HA SEW11405529HA SEW11405536HA SEW11507853HA SEW11507854HA SEW11507856HA SEW13380392HA SEW13380393HA SEW13380394HA SEW13380395HA SEW13380396HA SEW13380397HA SEW13380416HA SEW13380417HA SEW13380418HA SEW13380419HA SEW13380420HA SEW13380421HA SEW13380532HA SKA13370163GA SKA13370165GA SKA13370169GA SKA13370172GA SKA13370173GA SKA13370175GA SKA13370176GA SKA13370177GA SKA13370178GA SKA13370179GA SKA13370180GA SKA13370182GA SKA13370183GA  SEW13380157HA SEW13380158HA SEW13380162HA SEW13380206HA SEW13380207HA SEW13380208HA SEW13380270HA SEW13380272HA SEW13380274HA SEW13380280HA SEW13380281HA SEW13380282HA SEW13380283HA SEW13380284HA SEW13380285HA SEW13380288HA SEW13380289HA SEW13380290HA SEW13380291HA SEW13380292HA SEW13380293HA SEW13380295HA SEW13380296HA SEW13380297HA SEW13380298HA SEW13380299HA SEW13380301HA SEW13380312HA SEW13380314HA SEW13380315HA SEW13380316HA SEW13380317HA SKA13360151GA SKA13360154GA  SEW13380518HA SEW13401073HA SEW13380309HA SEW13380389HA SEW13380401HA SEW13380403HA SEW13380404HA SEW13380405HA SEW13380411HA  SEW13379847HA SEW13379861HA SKA13370174GA SKA13370181GA SKA13370184GA SKA13370187GA SKA13370188GA SKA13370190GA SKA13370191GA SKA13370192GA SEW13380278HA SEW13380279HA SEW13380287HA SEW13380294HA SEW13380300HA SEW13380307HA SEW13380311HA SEW13380398HA SEW13380519HA SEW13380521HA SEW13380522HA SEW13390703HA SKA13360153GA SEW13380510HA SEW13380530HA SEW13380539HA SEW13380543HA SEW13380544HA SEW13380555HA SEW13390701HA SEW13390702HA SEW13380414HA SEW13380448HA SEW13380449HA SEW13380450HA SEW13380451HA SEW13380458HA SEW13380460HA     SED10384090GA SED10394175GA SED10394176GA SED10404203GA SED10404204GA SED10404209GA SED10404210GA SED10404257GA SED11310355GA SED11461107GA SED11461113GA SED11461116GA SED11461119GA SED11461120GA SED11461121GA SED11461123GA SED12051712GA SED12051713GA SED12051714GA SED12051715GA SED12051717GA SED12051718GA SED12051726GA SED12051727GA SED12051728GA SED12051729GA SED12051730GA SED12051731GA SED12051732GA SED12051734GA SED12051738GA SED12061859GA SED12061861GA SED12061863GA SED12061864GA SED12061865GA SED12061866GA SED12061870GA SED12061871GA SED12061874GA SED12061875GA SED12071892GA SED12071896GA SED12071899GA SED12071900GA SED12082106GA SED12082108GA SED12082144GA SED12082156GA SED12082158GA SED12082165GA SED12082169GA SED12082170GA SED12082199GA SED12394520GA SED12394580GA SED12394585GA SED12394589GA SED12394598GA SED12394694GA SED12394704GA SED12475648GA SED12485742GA SED12485782GA SEW10293722HA SEW10467037HA SEW10467141HA SEW10467161HA SEW10467163HA SEW10467174HA SEW10467179HA SEW10467181HA SEW10467182HA SEW10467183HA SEW10467185HA SEW12193055HA SEW13380273HA SEW13380302HA SEW13380303HA SEW13380304HA SEW13380308HA SEW13380310HA SEW13380318HA SEW13380320HA SEW13380321HA SEW13380366HA SEW13380369HA SEW13380370HA SEW13380372HA SEW13380374HA SEW13380376HA SEW13380378HA SEW13380379HA SEW13380380HA SEW13380381HA SEW13380382HA SEW13380383HA SEW13380384HA SEW13380385HA SEW13380388HA SEW13380390HA SEW13380406HA SEW13380407HA SEW13380408HA SEW13380409HA SEW13380410HA SEW13380412HA SEW13380428HA SEW13380430HA SEW13380431HA SEW13380457HA SEW13380462HA SEW13380513HA SEW13380515HA SEW13380523HA SEW13380540HA SEW13380546HA SEW13380547HA SEW13380548HA SEW13380549HA SEW13380550HA SEW13380551HA SEW13380553HA SEW13380554HA SEW13390698HA SEW13390699HA SEW13390712HA SEW13390719HA SEW13390720HA SEW13390775HA SKA13130069GA SKA13130070GA SKA13130072GA SKA13130073GA SKA13130079GA SKA13130080GA SKA13130081GA SKA13130083GA SKA13130084GA SKA13130086GA SKA13130087GA SKA13130097GA SKA13130098GA SKA13130099GA SKA13360155GA SKA13370164GA SKA13370166GA SKA13370168GA SKA13370171GA SKA13370185GA SKA13370186GA SKA13370189GA SKA13370193GA SKA13370195GA SKA13370196GA SKA13370197GA SKA13370198GA SKA13370199GA SKA13370200GA SKA13370201GA SKA13370202GA SKA13370203GA SKA13370204GA SKA13370209GA SKA13370257GA SKA13370259GA SKA13370264GA

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.

GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. || K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. K131414 CARESCAPE MONITOR B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N