FDA.reportPublic FDA data

Modality Manager

Primary DI
00812345027440
Brand
Modality Manager
Company
MORTARA INSTRUMENT, INC.
Model
MODALITYMGR-5AC-AXXXX
Device description
Cardiology Information System Workstation
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
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
00812345027440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812345027440008123450274408123450274400812345027440

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac stress exercise monitoring systemAn assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a predetermined kind, e.g., an ergometer. The system will typically analyse the recorded data, display results, monitor various functions, provide control of the workload, and give printouts, providing the clinician with a complete representation of the electrical activity of the heart, including heart rate.

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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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
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14250892907489JaegerJaeger Medical GmbHDPS2025-06-06
14250892907632JaegerJaeger Medical GmbHDPS2025-06-06
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14250892907823JaegerJaeger Medical GmbHDPS2025-06-06
14250892907854JaegerJaeger Medical GmbHDPS2025-06-06
14250892907861JaegerJaeger Medical GmbHDPS2025-06-06