FDA.reportPublic FDA data

CARESCAPE Software

Primary DI
00840682147811
Brand
CARESCAPE Software
Company
GE Healthcare Finland Oy
Model
3.2
Catalog number
NA
Device description
SOFTWARE V3.2
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
FLLContinuous Measurement Thermometer
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
K213181000
K213336000
K213363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213181000CARESCAPE B650, E-musbGE Healthcare Finland Oy2022-04-13MHX
K213336000Carescape B850, E-musbGE Healthcare Finland Oy2022-04-13MHX
K213363000CARESCAPE B450, E-musbGE Healthcare Finland Oy2022-04-13MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682147811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682147811008406821478118406821478110840682147811

GMDN Terms#

Term, Definition table
TermDefinition
Physiologic monitor-installed softwareAn application software program intended to be installed on a dedicated monitoring device (i.e., software in a medical device), to process and display real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] to facilitate data viewing, management, and communication in a clinical setting. It may in addition notify clinicians of events, patients at risk, and/or manage workflows. It is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring.

Regulatory Flags#

DUNS number
401966697
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278699923PORTRAIT MMP01MMP015514246-302023-10-26
00195278110435PORTRAIT MMP01MMP0155142462023-09-01
00840682103152TruSignal SpO2TS-F2-GE2016-06-16
00195278093998PORTRAIT HUB01HUB012096437-0012023-09-01
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00198953066560NAPiCCO Injectate Sensor Cable2026-01-05
00198953030981PORTRAIT HSWXBV1.25700672-122025-12-10
00840682136402NACardiac Output Cable, 2.4 m/8 ft.2104180-0022018-08-10
00840682102872NAD-lite Spirometry Kit 2m 7ft, 80043812016-08-15
00840682103169TruSignal SpO2TS-F4-MC2016-07-15
00840682103190TruSignal SpO2TS-F4-N2016-06-16
00840682103343TruSignal SpO2TS-F1-H2016-06-16
00840682103367TruSignal SpO2TS-E4-H2016-06-16
00840682103381TruSignal SpO2TS-E4-N2016-06-16
00840682103442NAPre-conf. EEG Lead Set 2 General, 8980512016-06-16
00840682136358NAInvasive Blood Pressure Cable, Argon, Single, 1.2 2104166-0022018-08-10
00840682136365NAInvasive Blood Pressure Cable, Utah/Biotrans, Sing2104107-0022018-08-13
00840682136464NAInvasive Blood Pressure Cable, Utah/Biotrans, Dual2104107-0042018-08-10
00840682136501NAInvasive Blood Pressure Cable, ICU Medical Transpa2104158-0042018-08-10
00840682136525NAInvasive Blood Pressure Cable, Edwards LS TruWave,2104162-0042018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
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