FDA.reportPublic FDA data

Care Assist

Primary DI
00884838129221
Brand
Care Assist
Company
Philips Medizin Systeme Böblingen GmbH
Model
4.6
Catalog number
989803221531
Device description
Care Assist
Published
2026-03-09
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
DSHRecorder, Magnetic Tape, Medical
DSIDetector And Alarm, Arrhythmia
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MLDMonitor, St Segment With Alarm
MSXSystem, Network And Communication, Physiological Monitors
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838129221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838129221008848381292218848381292210884838129221

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)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314101143
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838119192Telemetry AccessoriesTelemetry Adapter Masimo SpO2-only9898032023912026-05-28
00884838119208Telemetry AccessoriesECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112026-05-28
00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
00884838094826Cardiac WorkstationCardiac Workstation 50008604392025-01-24
00884838094833Cardiac WorkstationCardiac Workstation 70008604412025-01-24
00884838132320Patient Information Center iXPatient Information Center iX 4.88663892026-07-13
00884838132337Care AssistCare Assist iOS 4.89898032215312026-07-13
00884838132344Care AssistCare Assist Android 4.89898032215412026-07-13
00884838119017Telemetry AccessoriesECG 3 lead Grabber, AAMI + SpO2, Tele9898031718112026-05-28
00884838119024Telemetry AccessoriesECG 5 lead Snaps, AAMI, Tele9898031718212026-05-28
00884838119031Telemetry AccessoriesECG 5 lead Grabber, AAMI, Tele9898031718312026-05-28
00884838119048Telemetry AccessoriesECG 5 lead Snaps, AAMI + SpO2, Tele9898031718412026-05-28
00884838119055Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2, Tele9898031718512026-05-28
00884838119062Telemetry AccessoriesECG 6 lead Grabber, AAMI, Tele9898031718612026-05-28
00884838119185Telemetry AccessoriesTelemetry Adapter 5-Lead + Masimo SpO29898032023812026-05-28
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
P00020eWave Electrode PatchWearlinq, Inc.DSH2026-07-14
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675723639Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675723646Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785477Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785484Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785491Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675786108Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797173Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797180Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13