FDA.reportPublic FDA data

Care Assist

Primary DI
00884838129238
Brand
Care Assist
Company
Philips Medizin Systeme Böblingen GmbH
Model
4.7
Catalog number
989803221541
Device description
Care Assist
Published
2026-04-17
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
00884838129238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838129238008848381292388848381292380884838129238

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
314101143
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26
00884838119130Telemetry AccessoriesECG Trunk Cable AAMI/IEC9898031722212026-05-26
00884838119147Telemetry AccessoriesTelemetry Adapter 6L+SpO29898031990712026-05-26
00884838119154Telemetry AccessoriesTelemetry Adapter SpO2-only9898031990812026-05-26
00884838119161Telemetry AccessoriesTelemetry Adapter 5L+SpO29898031990912026-05-26
00884838119178Telemetry AccessoriesTelemetry Adapter 3L+SpO29898031991012026-05-26
20884838119233Telemetry AccessoriesECG 5 lead Grabber, AAMI, SPU, Tele9898031720312026-05-26
20884838119240Telemetry AccessoriesECG 5 lead Grabber, IEC, SPU, Tele9898031721312026-05-26
00884838117396patient lead wire12L Leadset, Grabber, AAMI9898031801212026-05-21
00884838117402patient lead wire12L Leadset, Grabber, IEC9898031801312026-05-21
00884838117419patient lead wire12L Leadset, Snaps, AAMI9898031801412026-05-21
00884838117426patient lead wire12L Leadset, Snaps, IEC9898031801512026-05-21
20884838119769Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2,SPU,Tele9898031720512026-05-19
20884838119776Telemetry AccessoriesECG 5 Lead Grabber IEC + SpO2, SPU, Tele9898031721512026-05-19
00884838107816Measurement Rack 6000Measurement Rack 60008673172026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
G2871002HUMAMedoPad Inc.MSX2025-04-28
10841522131141XhibitSPACELABS HEALTHCARE (WASHINGTON), INCMSX2024-07-04
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.MSX2024-06-19
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMSX2024-06-07
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMLD2024-06-07
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
10841522129780XhibitSPACELABS HEALTHCARE (WASHINGTON), INCMSX2024-06-07
10841522129797TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16
10841522129803TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16
08885018690106Everion+ System Adjustable ArmbandBIOFOURMIS SINGAPORE PTE. LTD.MSX2023-05-02
08885018690090Everion+ System Adjustable ArmbandBIOFOURMIS SINGAPORE PTE. LTD.MSX2023-05-02
08885018690007Everion+ SystemBIOFOURMIS SINGAPORE PTE. LTD.MSX2023-03-22
08800069700178AT-PatchATsens Co., Ltd.DSH2022-12-23
07613327468458N/ASTRYKER CORPORATIONOUG2022-11-04
18033737712341THD Procto Software SystemTHD SPAOUG2022-10-07
09420012424266Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDOUG2022-08-02
08033737713037THD Procto Software SystemTHD SPAOUG2021-07-19
18033737712389THD Procto Software SystemTHD SPAOUG2021-07-19
07613327482652N/ASTRYKER CORPORATIONOUG2021-07-13
15099169715117VitaloJAKVITALOGRAPH (IRELAND) LIMITEDDSH2021-06-18
07613327467888SaboSTRYKER CORPORATIONOUG2021-06-17
07613327467871NASTRYKER CORPORATIONOUG2021-06-15
09352527001185Visionflex VISIONFLEX PTY. LTD.OUG2021-02-19
09352527001192Visionflex VISIONFLEX PTY. LTD.OUG2021-02-19
07613327505245ADAPTStryker Leibinger GmbH & Co. KGOUG2020-06-18