FDA.reportPublic FDA data

Mediblu

Primary DI
00199874152509
Brand
Mediblu
Company
MEDIBLU MEDICAL LLC
Model
MB12
Catalog number
MDB01046
Device description
Patient Monitor
Published
2025-12-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250179000Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.2025-07-29MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199874152509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199874152509001998741525091998741525090199874152509

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13054063931regulatory@strenamedical.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
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
B632MDB01027MedibluS12WMDB010272020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
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