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Epicardia 5000

FDA UDI

Class II (US FDA UDI)

by Medicomp, Inc.

Identity

Trade Name
Epicardia 5000 FDA UDI
Generic Name
Cardiology information system application software FDA UDI
Device Name
Epicardia 5000 is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. FDA UDI
Model / Reference
N/A FDA UDI
Description
Epicardia 5000 is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. FDA UDI

Identifiers

Primary DI / UDI-DI
00862887000302 FDA UDI
510(k) Number
K090834 FDA UDI
FDA Product Code
DSI FDA UDI
GMDN Term
Cardiology information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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

No

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: Cardiology information system application software

Epicardia 5000 by Medicomp, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiology information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medicomp, Inc.

Sources (1)

  • FDA UDI 609cfadd-28cf-4635-9eb9-8d4d1801d7b2 34 fields · synced Jun 8, 2026