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Pyramis

FDA UDI

Class II (US FDA UDI)

by Mortara Instrument, Inc.

Identity

Trade Name
Pyramis FDA UDI
Generic Name
Patient health record information system application software FDA UDI
Device Name
Cardiology Data Management System FDA UDI
Model / Reference
11095-002-61 FDA UDI
Description
Cardiology Data Management System FDA UDI

Identifiers

Primary DI / UDI-DI
00812345024784 FDA UDI
510(k) Number
K032038 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Patient health record information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient health record information system application software

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

Similar devices

Also classified as Patient health record information system application software.

Cleared under the same submission

K032038 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mortara Instrument, Inc.

Sources (1)

  • FDA UDI d83f0b17-19fa-4add-b40d-e785a2b31e24 35 fields · synced Jun 8, 2026