FDA.reportPublic FDA data

eCareManager

Primary DI
00884838101050
Brand
eCareManager
Company
VISICU, INC.
Model
4.4
Catalog number
865325
Device description
Telehealth Center Product License
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171322000eCareManager 4.1Visicu, Inc.2017-08-03MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838101050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838101050008848381010508848381010500884838101050

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx
+1 877 374-2872eicusupport@philips.com

Regulatory Flags#

DUNS number
053869348
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838102910eCareManager4.58653252020-11-30
00884838099807eCareManager4.38653252020-04-17
00884838087453eCareManager4.28653252018-11-15
00884838115460eCareManager4.78653252023-06-21
00884838106963eCareManager4.68653252022-11-10
00884838059368eCareManager4.08653252015-09-20
00884838059832eCareManager4.18653252016-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850064210132ANNE View Patient MonitorSibel Health Inc.MSX2025-03-26
00884838126381eCareManagerPhilips Medical Systems Nederland B.V.MSX2025-03-17
00860011811961MessengerSPOK INC.MSX2025-02-19
04048675673408Gateway Software Server VF9.0.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675762256Gateway Software Server VF9.1.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675777762Gateway Software Server VF9.1.2DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098007061Infinity Gateway USB DongleDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098099264S/W SUB VF9.0 GatewayDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19