FDA.reportPublic FDA data

Care Assist

Primary DI
00884838123724
Brand
Care Assist
Company
Philips Medical Systems Hsg
Model
4.2
Catalog number
989803221541
Device description
Care Assist
Published
2024-11-27
Public version status
Update
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
00884838123724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838123724008848381237248848381237240884838123724

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
790605856
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838015245HeartStartExternal Paddles Water ResistantM3543A2014-09-24
00884838090088MX40 Masimo Leadsets and AdaptersMX40 Adapter 5-Lead + Masimo SpO29898032023812022-05-23
00884838090095MX40 Masimo Leadsets and AdaptersMX40 Adapter Masimo SpO2-only9898032023912022-05-23
00884838090101MX40 Masimo Leadsets and AdaptersECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112020-04-21
00884838090118MX40 Masimo Leadsets and AdaptersECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212020-04-21
00884838091276MX40 Masimo Leadsets and AdaptersMX40 Adapter 6-Lead + Masimo SpO29898032042912020-04-21
00884838013360ECG ElectrodesCBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE9898031718112017-07-13
00884838013377ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI, TELE9898031718212016-10-13
00884838013384ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, TELE9898031718312016-09-27
00884838013391ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI + SPO2, TELE9898031718412016-09-27
00884838013407ECG ElectrodesCBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE9898031718512016-09-27
00884838013414ECG ElectrodesCBL ECG 6 LEAD GRABBER, AAMI, TELE9898031718612017-07-27
20884838013517ECG ElectrodesCBL ECG 5 LEAD GRABBER IEC, SPU, TELE9898031721312020-03-25
20884838013494ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE9898031720312016-10-12
00884838013421ECG ElectrodesCBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE9898031718712016-11-22
00884838013445ECG ElectrodesCBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE9898031719112016-11-29
00884838013452ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC, TELE9898031719312016-10-13
00884838013469ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE9898031719512016-10-13
00884838013476ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC, TELE9898031719612016-11-01
00884838013483ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE9898031719712016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860006582012TigerConnect Alarm ManagementCritical AlertMSX2026-05-29
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
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), INCMLD2024-06-07
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMSX2024-06-07
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