FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094327496
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901143
Catalog number
HSCRIBE-6AA-AAXXD
Device description
"HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24"" monitor with 1920 x 1080 resolution; US power cord; HP LaserJet 110V printer; Rx Report Export (UNIPRO and waveform XML) + XML Orders"
Published
2023-09-15
Public version status
New
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094327496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094327496007320943274967320943274960732094327496

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

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22
00732094322927Welch Allyn, Inc.901134ESCRIBE-BEX-CXACA2019-07-22
00732094322934Welch Allyn, Inc.901134ESCRIBE-BEX-CXAAA2019-07-22
00732094322941Welch Allyn, Inc.901134ESCRIBE-BAX-DXACX2019-07-22
00732094322958Welch Allyn, Inc.901134ESCRIBE-BAX-DXACB2019-07-22
00732094322965Welch Allyn, Inc.901134ESCRIBE-BAX-CXXXX2019-07-22
00732094322972Welch Allyn, Inc.901134ESCRIBE-BAX-CXACB2019-07-22
00732094322989Welch Allyn, Inc.901134ESCRIBE-BAX-CXACA2019-07-22
00732094322996Welch Allyn, Inc.901134ESCRIBE-BAX-CXAAX2019-07-22
00732094323009Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXX2019-07-22
00732094323016Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXA2019-07-22
00732094323023Welch Allyn, Inc.901134ESCRIBE-AEX-CXAXA2019-07-22
00732094323030Welch Allyn, Inc.901134ESCRIBE-AEX-CXAAA2019-07-22
00732094323047Welch Allyn, Inc.901134ESCRIBE-AAX-DXXXX2019-07-22
00732094323054Welch Allyn, Inc.901134ESCRIBE-AAX-CXXXX2019-07-22

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
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
B146C2MA000Millennia SoftwareBRAEMAR MANUFACTURING, LLCMLO2019-10-10