FDA.reportPublic FDA data

Mobile Care

Primary DI
00840682106498
Brand
Mobile Care
Company
GE Healthcare Finland Oy
Model
Web Viewer
Device description
SW-MED, MOBILE CARE SOFTWARE, VER 6.3
Published
2016-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MSXSYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682106498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682106498008406821064988406821064980840682106498

GMDN Terms#

Term, Definition table
TermDefinition
Centralized patient monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

Regulatory Flags#

DUNS number
401966697
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00195278466662E-EEGXMJD1012022-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.MSX2026-06-02
08720256776659Strap Silicon BlueCorsano Health B.V.MSX2026-06-02
08720256776987Charge Station 10 Sensors ACorsano Health B.V.MSX2026-06-02
00860006582012TigerConnect Alarm ManagementCritical AlertMSX2026-05-29
00884838107816Measurement Rack 6000Philips Medizin Systeme Böblingen GmbHMSX2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MSX2026-03-18
B153301030AirStrip ONE Client WebAirstrip Technologies, Inc.MSX2026-03-18
B153500010AirStrip Alarm ManagementAirstrip Technologies, Inc.MSX2026-03-18
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00843997019019Patient SafetyNet LiteMASIMO CORPORATIONMSX2026-02-23
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyMSX2025-12-10
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCMSX2025-06-30
00853858006584EmpaticaEMPATICA SRLMSX2025-06-26
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
G2871002HUMAMedoPad Inc.MSX2025-04-28
00850064210262Sibel Spacelabs Trek TabletSibel Health Inc.MSX2025-04-02
00850064210163Central Hub CMSSibel Health Inc.MSX2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.MSX2025-03-27