FDA.reportPublic FDA data

Modality Manager

Primary DI
00817655022420
Brand
Modality Manager
Company
MORTARA INSTRUMENT, INC.
Model
MDLTYMGR-5AC-XXXXB
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
OTC
false
Sterile
false
Single use
false

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
00817655022420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817655022420008176550224208176550224200817655022420

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
21081234502471Quik-Prep031581-002016-09-24
10812345022176Clear Choice Adapter9325-003-502016-09-24
10812345023050Snap Adapter9281-002-502016-09-24
20812345024238Quick-Trace Multi-purpose ECG electrodes000310-0012016-09-24
30812345024686CardioSens/Ultra II047029-002016-09-24
30812345024723Resting Tab Type Electrodes9300-033-502016-09-24
20812345024733ECG Monitoring Electrodes9300-032-522016-09-24
21081234502474Quik-Prep031581-002016-09-24
30812345026024Holter Prep KitXKTHOLT5LA2016-09-24
10812345029939Holter Prep Kit0432722016-09-24
00817655020020ELI 250cELI250c-MAA-AAHBB2016-09-24
00817655020037ELI 280 ELI280-CAA-AAFBT2016-09-24
00817655020044ELI PC11066-001-70 2016-09-24
00817655020051XScribe Cardiopulmonary Kit41000-030-602016-09-24
00817655020068XScribe Cardiopulmonary Kit41000-030-622016-09-24
00817655020075Q-StressQS-6GC-AXXXB2016-09-24
00817655020082XScribeXSCRIBE-6BB-AAAXA2016-09-24
00817655020099WAM30012-020-602016-09-24
00817655020105Q-Tel RMS11089-001-702016-09-24
00817655020112HScribeHSCRIBE-6AA-AAXXB2016-09-24

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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
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00732094338812Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-09-14
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B146C4MA000Millennia SoftwareBRAEMAR MANUFACTURING, LLCMLO2019-10-10
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B146C1MA070Millennia SoftwareBRAEMAR MANUFACTURING, LLCMLO2019-10-09
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