FDA.reportPublic FDA data

Mediblu

Primary DI
B632MDB01010
Brand
Mediblu
Company
MEDIBLU MEDICAL LLC
Model
ME3
Catalog number
MDB01010
Published
2020-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B632MDB01010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

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
B632MDB01011MedibluME6PMDB010112020-06-25
B632MDB01012MedibluME12PMDB010122020-06-25
B632MDB01026MedibluS12MDB010262020-06-25
B632MDB01027MedibluS12WMDB010272020-06-25

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Primary DI, Brand, Company table
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