FDA.reportPublic FDA data

CARESCAPE B850

Primary DI
00840682146142
Brand
CARESCAPE B850
Company
GE Healthcare Finland Oy
Model
MBC323
Catalog number
5805690
Device description
CARESCAPE B850 MBC323 (ATO MODEL)
Published
2022-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
BZKSpirometer, monitoring (w/wo alarm)
BZLCOMPUTER, OXYGEN-UPTAKE
BZQMonitor, breathing frequency
CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
CBQANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
CBRANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
CBSANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE
DPSElectrocardiograph
DPZOximeter, ear
DQAOximeter
DQKComputer, diagnostic, programmable
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DSIDETECTOR AND ALARM, ARRHYTHMIA
DSJAlarm, blood-pressure
DSKCOMPUTER, BLOOD-PRESSURE
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
DXNSystem, measurement, blood-pressure, non-invasive
FLLThermometer, electronic, clinical
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
KOISTIMULATOR, NERVE, PERIPHERAL, ELECTRIC
KRBPROBE, THERMODILUTION
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
MLDMONITOR, ST SEGMENT WITH ALARM
MUDOximeter, tissue saturation
NHOAnalyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
NHPAnalyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
NHQAnalyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
OLTNon-normalizing quantitative electroencephalograph software
OLWIndex-generating electroencephalograph software
OMCReduced- montage standard electroencephalograph
ORTBurst suppression detection software for electroencephalograph
QEMCerebral oximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2
BZLComputer, Oxygen-UptakeAnesthesiology2
BZQMonitor, Breathing FrequencyAnesthesiology2
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Anesthesiology2
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
DPSElectrocardiographCardiovascular2
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
KOIStimulator, Nerve, Peripheral, ElectricAnesthesiology2
KRBProbe, ThermodilutionCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2
MUDOximeter, Tissue SaturationCardiovascular2
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLWIndex-Generating Electroencephalograph SoftwareNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2
QEMCerebral OximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213336000Carescape B850, E-musbGE Healthcare Finland Oy2022-04-13MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682146142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682146142008406821461428406821461420840682146142

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401966697
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103022OxyTip SpO2OXY-FMR-002016-06-16
00840682103077OxyTip SpO2OXY-WMR-002016-06-16
00195278949752TruSignal SpO2 MM 3.0M159769772026-10-04
00195278949769TruSignal SpO2 MM 1.8M159560152026-10-04
00198953002186Carescape Dock F0157006022026-10-04
00840682106498Mobile CareWeb Viewer2016-06-21
00198953009567Carescape ONE259560312026-10-04
00840682102957EntropyGE Entropy sensor, M10386812016-08-15
00840682102971EntropyEasyFit sensor, M11744132016-08-15
00840682102964EntropyEntropy Cable, M1050784M10507842016-06-30
00840682103015NAPiCCO Injectate Sensor Cable2016-06-10
00840682103039NAPiCCO Continuous Cardiac Output Cable2016-06-16
00840682102841NAD-Lite Spirometry Kit 3m/10ft, 80043822016-08-15
00840682102858NAPedi-Lite Spirometry Kit 3m, M10326342016-08-15
00840682102865NAPedi-lite Spirometry Kit 2m, 80027182016-08-15
00840682102926NAMini D-fend Water Trap, 800217480021742016-08-12
00840682102896NACalibration Gas, 7555872016-06-10
00840682102902NACalibration Gas, 755571-HEL2016-06-10
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00860011800613CardioTagCARDIOSENSE, INC.DPS2026-10-14
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00195278840202MACGe Medical Systems Information Technologies, Inc.DPS2026-10-13
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
06973826012240AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012257AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012264AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012271AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012288AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09