FDA.reportPublic FDA data

Flexible Module Server FMX-4

Primary DI
00884838086982
Brand
Flexible Module Server FMX-4
Company
Philips Medizin Systeme Böblingen GmbH
Model
Flexible Module Server FMX-4
Catalog number
866468
Device description
The IntelliVue FMX-4 Flexible Module Rack provides 4 module slots for use with individual measurement modules and the recorder. The optional E20 Multi Measurement Module mount provides a mounting plate with an SRL connector for attaching a multi-measurement module. The FMX-4 is only compatible with IntelliVue MX750 and MX850 patient monitors.
Published
2021-11-29
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210906000IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4Philips Medizin Systeme Boeblingen GmbH2021-10-07MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838086982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838086982008848380869828848380869820884838086982

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module rackA device typically designed as a framework or specially constructed holder where module devices used with a patient monitoring system can be plugged in and connected to the parent device usually by one cable. This device is typically used to facilitate connection to the patient from the modules using standard length cables and leads when the parent device is situated away from the patient (out of reach), e.g., the parent device may be mounted to a wall support or a ceiling pendant arm (Utility supply system).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure57 KiloPascal107.5 KiloPascal
Storage Environment Atmospheric Pressure570 KiloPascal1060 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314101143
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
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Primary DI, Brand, Company table
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