FDA.reportPublic FDA data

Mediblu

Primary DI
B632MDB01037
Brand
Mediblu
Company
MEDIBLU MEDICAL LLC
Model
MM1
Catalog number
MDB01037
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
B632MDB01037PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(305)406-3931Fernando.ramon@medisono.com

Regulatory Flags#

DUNS number
117518078
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199874152509MedibluMB12MDB010462025-12-23
00199874432199MedibluMB15MDB010472025-12-23
00199874784175MedibluMBV1MDB010482025-12-23
B632MDB01042MedibluHA12PMDB010422023-11-17
B632MDB01040MedibluME15PMDB010402023-09-29
B632MDB01008MedibluFM02MDB010082020-06-25
B632MDB01001MedibluMM17MDB010012020-06-25
B632MDB01002MedibluMM15MDB010022020-06-25
B632MDB01003MedibluMM12MDB010032020-06-25
B632MDB01004MedibluMM5MDB010042020-06-25
B632MDB01005MedibluMM3MDB010052020-06-25
B632MDB01006MedibluMO1MDB010062020-06-25
B632MDB01007MedibluFM10MDB010072020-06-25
B632MDB01028MedibluBLU 12MDB010282020-06-25
B632MDB01034MedibluBLU 12+MDB010342020-06-25
B632MDB01035MedibluBlu15+MDB010352020-06-25
B632MDB01010MedibluME3MDB010102020-06-25
B632MDB01011MedibluME6PMDB010112020-06-25
B632MDB01012MedibluME12PMDB010122020-06-25
B632MDB01026MedibluS12MDB010262020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226113FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226922FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612228070FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612230370FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
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
04048675797197Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
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