FDA.report

Modality Manager

Primary DI
00817655022352
Brand
Modality Manager
Company
MORTARA INSTRUMENT, INC.
Model
MDLTYMGR-5AC-BXXXX
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

Related Records

Contact Domains

Product Codes

CodeName
DPSElectrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817655022352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817655022352008176550223528176550223520817655022352

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit149 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

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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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