FDA.reportPublic FDA data

Telemetry Monitor 5500 1.4 GHz Radio

Primary DI
00884838102842
Brand
Telemetry Monitor 5500 1.4 GHz Radio
Company
Philips Medical Systems DMC GmbH
Model
Telemetry Monitor 5500 1.4 GHz Radio
Catalog number
867232
Device description
The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Central Station Patient Information Center (PIC) iX.
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838102842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838102842008848381028428848381028420884838102842

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography monitoring system receiverAn electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
314101218
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00884838116016Radiography 7300 C7120372024-06-27
00884838103221ProxiDiagnost N907061102022-01-17
00884838101456CombiDiagnost R907090312021-02-04
00884838090699DigitalDiagnost C907120342019-03-28
00884838090705DigitalDiagnost C907120352019-03-28
00884838065321DigitalDiagnost7120317120312016-09-19
00884838074514DigitalDiagnost7120327120322016-09-19
00884838074521DigitalDiagnost7120337120332016-09-19
00884838076747CombiDiagnost R907090307090302018-05-09
00884838127517CT XS Tube CPO9806-058-000919806-058-000912025-07-31
00884838125322Grid Landscape for SkyPlate E 9896-010-725122025-06-19
00884838125339Grid Landscape for SkyPlate large 9896-010-686242025-06-19
00884838125346Grid Portrait for SkyPlate E 9896-010-725022025-06-19
00884838125353Grid Portrait for SkyPlate large9896-010-686332025-06-19
00884838125360Grid Portrait for SkyPlate small 9896-010-686442025-06-19
00884838125384Grid Portrait Fiber PaxScan4336W9896-010-708322025-06-19
00884838125391Grid Landscape Fiber PaxScan4336W9896-010-708222025-06-19
00884838125421X-Ray Grid 40/12/1409896-010-648922025-06-19
00884838125438X-Ray Grid 40/12/180 9896-010-646722025-06-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMHX2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyMHX2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyMHX2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyMHX2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyMHX2022-07-01
00840682146111CARESCAPE B650GE Healthcare Finland OyMHX2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyMHX2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyMHX2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.MHX2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.MHX2022-04-12