Modality Manager

FDA UDI

Class II (US FDA UDI)

by Mortara Instrument, Inc.

Identity

Trade Name: Modality Manager FDA UDI
Generic Name: Cardiac stress exercise monitoring system FDA UDI
Device Name: Cardiology Information System Workstation FDA UDI
Model / Reference: MODALITYMGR-5AE-AXXXB FDA UDI
Description: Cardiology Information System Workstation FDA UDI

Identifiers

Primary DI / UDI-DI: 00812345027464 FDA UDI
FDA Product Code: DPS FDA UDI
MLO FDA UDI
GMDN Term: Cardiac stress exercise monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 FDA UDI
870.2800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiograph, professional, multichannel Electrocardiographic long-term ambulatory recording analyser application software Cardiac stress exercise monitoring system

Modality Manager by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mortara Instrument, Inc.

Sources (1)

FDA UDI c6b1ed24-a4e8-4c5d-a559-8a1fe8e0ddfe 35 fields · synced Jun 1, 2026