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Modality Manager MODALITYMGR-5AE-AXXXB

by Mortara Instrument, Inc.

Modality Manager MODALITYMGR-5AE-AXXXB is a Class II device made by Mortara Instrument, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345027464), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812345027464 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Modality Manager
Generic name
Cardiac stress exercise monitoring system
Model / reference
MODALITYMGR-5AE-AXXXB
Primary DI / UDI-DI
00812345027464
FDA product code
DPS, MLO
GMDN term
Cardiac stress exercise monitoring system
Device class
Class II
Regulation number
870.2340, 870.2800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DPS (Electrocardiograph).

Other devices from Mortara Instrument, Inc.

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)