FDA.reportPublic FDA data

MIDMARK IQHOLTER® PLUG-IN SOFTWARE

Primary DI
00841709118067
Brand
MIDMARK IQHOLTER® PLUG-IN SOFTWARE
Company
MIDMARK CORPORATION
Model
P/N 4-100-3140
Device description
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
Published
2020-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K031466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031466000IQMARK DIGITAL HOLTERBrentwood Medical Technology Corp.2003-06-11MLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709118067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709118067008417091180678417091180670841709118067

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006436275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709105715MidmarkQC3R-01QC3R-012017-06-23
00841709105722MidmarkQC6R-01QC6R-012017-06-23
00841709112577MidmarkDCV5-G2X/HDCV5-G2X/H2021-01-15
00841709112713MidmarkDCV6-G2X/HDCV6-G2X/H2021-01-15
00841709112850MidmarkDCV7-G2X/HDCV7-G2X/H2021-01-15
00841709112928MidmarkDCV8-G2X/HDCV8-G2X/H2021-01-15
00841709112997MidmarkDCVM-G0X/HDCVM-G0X/H2021-01-15
00841709103551MidmarkP7015V-PP7015V-P2017-02-16
00841709103575MidmarkP7016V-PP7016V-P2017-02-16
00841709103599MidmarkP7017V-PP7017V-P2017-02-16
00841709103605MidmarkP7018V-PP7018V-P2017-02-16
00841709108860Midmark153810-001153810-0012026-09-29
00841709108877Midmark153810-002153810-0022026-09-29
00841709108884Midmark153810-003153810-0032026-09-29
00841709109805Midmark153600-020153600-0202026-09-28
00841709109812Midmark153600-021153600-0212026-09-28
00841709109843Midmark153600-304153600-3042026-09-28
00841709109850Midmark153600-305153600-3052026-09-28
00841709109874Midmark153600-504153600-5042026-09-28
00841709109881Midmark153600-505153600-5052026-09-28

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Primary DI, Brand, Company table
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08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDMLO2025-02-07
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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
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
B146C2MA000Millennia SoftwareBRAEMAR MANUFACTURING, LLCMLO2019-10-10