FDA.reportPublic FDA data

Modality Manager

Primary DI
00817655022468
Brand
Modality Manager
Company
MORTARA INSTRUMENT, INC.
Model
MDLTYMGR-5BC-DXXXB
Device description
Cardiology Information System Workstation
Published
2017-10-11
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
DPSElectrocardiograph
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817655022468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817655022468008176550224688176550224680817655022468

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
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DPS2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DPS2026-04-03
00195278620873MACGe Medical Systems Information Technologies, Inc.DPS2026-03-31
10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23
10843997016015Radius VSMMASIMO CORPORATIONDPS2026-02-23
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DPS2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DPS2026-01-29
14250892908509JaegerJaeger Medical GmbHDPS2025-11-24
14250892908936JaegerJaeger Medical GmbHDPS2025-11-24
34250892909012JaegerJaeger Medical GmbHDPS2025-11-24
34250892909029JaegerJaeger Medical GmbHDPS2025-11-24
08800069700109AT-ReportATsens Co., Ltd.MLO2025-11-05
08800069700260AT-PatchATsens Co., Ltd.MLO2025-11-05
08800069700277AT-PatchATsens Co., Ltd.MLO2025-11-05
34250892908367JaegerJaeger Medical GmbHDPS2025-10-31
34250892908541JaegerJaeger Medical GmbHDPS2025-10-31
34250892908589JaegerJaeger Medical GmbHDPS2025-10-31
00817111021332PolysmithNeurotronics, LLCMLO2025-09-23
34250892907032JaegerJaeger Medical GmbHDPS2025-08-14
34250892907070JaegerJaeger Medical GmbHDPS2025-08-14
14250892909100JaegerJaeger Medical GmbHDPS2025-08-08
14250892907625JaegerJaeger Medical GmbHDPS2025-07-24
14250892907649JaegerJaeger Medical GmbHDPS2025-07-17
14250892908042JaegerJaeger Medical GmbHDPS2025-07-17
14250892907489JaegerJaeger Medical GmbHDPS2025-06-06
14250892907632JaegerJaeger Medical GmbHDPS2025-06-06
14250892907816JaegerJaeger Medical GmbHDPS2025-06-06
14250892907823JaegerJaeger Medical GmbHDPS2025-06-06
14250892907854JaegerJaeger Medical GmbHDPS2025-06-06
14250892907861JaegerJaeger Medical GmbHDPS2025-06-06