FDA.reportPublic FDA data

Millennia Software

Primary DI
B146C3MA020
Brand
Millennia Software
Company
BRAEMAR MANUFACTURING, LLC
Model
900-0620-02
Published
2019-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024323000CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000Biomedical Systems Corp.2003-06-30MLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B146C3MA020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049529118
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838128729C6 Monitor A13, Verizon02-023862025-10-06
00884838128736C6 Monitor A13, T Mobile02-023872025-10-06
B146C6R30C6 Sensor 3.0, Rebuilt02-021242024-06-26
B146EP25R0ePatch Sensor 2.5, Rebuilt02-022512024-06-26
B146C6M20C6 Monitor UGW100-0048-022019-10-08
B146EP2510ePatch 2.5, BTH02-020452023-01-20
B146EP2520ePatch 2.5, BTI02-020462023-11-22
B146C6M60C6 Monitor A10e, Sprint02-018002023-06-15
B146C6M80C6 Monitor A13, T Mobile02-021192023-06-15
B146C6M90C6 Monitor A13, Verizon02-021182023-06-15
B146EP2R10ePatch 2.0 rebuilt02-019972022-07-13
B146C6M70C6 Monitor A10e, Verizon02-018042022-03-21
B146C6E10C6 Sensor 3.002-018462021-04-28
B146C6R10C6 Sensor 2.5 rebuilt02-018892021-03-30
B146C6R20C6 Sensor 2.0 rebuilt02-018972021-03-30
B146BTPM0BTP-1000S Monitor100-0045-022020-07-15
B146C6M40C6 Monitor02-015492020-07-15
B146EP2020ePatch 2.0 BTI02-016502020-07-15
B146C6D0C6 Sensor D02-015612019-10-08
B146C6D10C6 Sensor 02-016062019-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069700109AT-ReportATsens Co., Ltd.MLO2025-11-05
08800069700260AT-PatchATsens Co., Ltd.MLO2025-11-05
08800069700277AT-PatchATsens Co., Ltd.MLO2025-11-05
00817111021332PolysmithNeurotronics, LLCMLO2025-09-23
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDMLO2025-02-07
00732094356861Welch Allyn, Inc.WELCH ALLYN, INC.MLO2024-12-18
00732094356878Welch Allyn, Inc.WELCH ALLYN, INC.MLO2024-12-18
00815187020754M12 SystemGLOBAL INSTRUMENTATION, LLCMLO2024-12-03
00862887000319TelePatch Cardiac MonitorMEDICOMP, INC.MLO2024-07-24
B632MDB01042MedibluMEDIBLU MEDICAL LLCMLO2023-11-17
00862887000388TelePatch Cardiac MonitorMEDICOMP, INC.MLO2023-09-25
00732094327496Welch Allyn, Inc.WELCH ALLYN, INC.MLO2023-09-15
00817111021257Polysmith Version 12.2Neurotronics, LLCMLO2022-12-28
90815187020696Matrix Holter SystemGLOBAL INSTRUMENTATION, LLCMLO2022-04-29
90815187020702Matrix Holter SystemGLOBAL INSTRUMENTATION, LLCMLO2022-04-29
90815187020719Matrix Holter SystemGLOBAL INSTRUMENTATION, LLCMLO2022-04-29
00732094350753Welch Allyn, Inc.WELCH ALLYN, INC.MLO2021-09-27
00732094345643Welch Allyn, Inc.WELCH ALLYN, INC.MLO2021-02-10
00841709118067MIDMARK IQHOLTER® PLUG-IN SOFTWAREMIDMARK CORPORATIONMLO2020-12-28
00732094338812Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-09-14
00884838094895Holter SoftwarePhilips Medical Systems HsgMLO2020-08-19
00860000272407Rhythm ExpressVIVAQUANT, INC.MLO2020-07-27
B146ER9WCNC0ER9W CDMA wEventBRAEMAR MANUFACTURING, LLCMLO2020-07-15
B146ERWCD020ER9W CDMA First Call MedBRAEMAR MANUFACTURING, LLCMLO2020-07-15
B146ERWCD030ER9W CDMA UNMBRAEMAR MANUFACTURING, LLCMLO2020-07-15
00817111021172Polysmith Version 12.0Neurotronics, LLCMLO2020-04-01
00732094263978Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-03-24
00732094281330Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-03-24
00732094261301Welch Allyn, Inc.WELCH ALLYN, INC.MLO2019-12-04
00732094325607Welch Allyn, Inc.WELCH ALLYN, INC.MLO2019-10-10