FDA.reportPublic FDA data

HScribe

Primary DI
00817655020136
Brand
HScribe
Company
MORTARA INSTRUMENT, INC.
Model
HSCRIBE-6AC-AXXXC
Device description
Holter Analysis System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K004017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K004017000H-SCRIBEMortara Instrument, Inc.2001-06-11MLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817655020136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817655020136008176550201368176550201360817655020136

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit149 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-667-8272techsupport@mortara.com

Regulatory Flags#

DUNS number
062046149
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812345023050Snap Adapter9281-002-502016-09-24
00817655020099WAM30012-020-602016-09-24
00817655020150WAM30012-020-512016-09-24
00817655020266WAM41000-034-502016-10-06
00817655020273WAM41000-034-512016-10-06
00817655020471WAM41000-029-522016-10-25
00817655020518WAM41000-029-602016-11-07
00817655020525WAM41000-029-612016-11-07
00817655020532WAM41000-029-702016-11-07
00817655020549WAM41000-029-712016-11-07
00817655021959WAM30012-019-4502017-09-08
00817655022031WAM30012-019-752017-09-19
00817655022048AM1241000-032-542017-09-19
00817655022055AM1241000-032-562017-09-19
00817655022062WAM41000-031-542017-09-19
00817655022079WAM41000-031-562017-09-19
00817655022741WAM41000-038-502017-11-14
00817655023137AM129293-048-652018-03-29
00812345021745WAM41000-031-502016-09-24
00812345021752WAM41000-031-522016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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