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Premier Heart MCG Analysis API

FDA UDI

Class II (US FDA UDI)

by Premier Heart, Llc

Identity

Trade Name
Premier Heart MCG Analysis API FDA UDI
Generic Name
Cardiopulmonary physiological parameter analysis software FDA UDI
Device Name
MCG Analysis API (Dedicated Server or Software-as-a-Service) FDA UDI
Model / Reference
MCGS FDA UDI
Description
MCG Analysis API (Dedicated Server or Software-as-a-Service) FDA UDI

Identifiers

Primary DI / UDI-DI
B320MCGS0 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiopulmonary physiological parameter analysis 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary physiological parameter analysis software

Premier Heart MCG Analysis API by Premier Heart, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary physiological parameter analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Premier Heart, Llc

Sources (1)

  • FDA UDI ecf0cfdf-40e8-44c4-bc3d-2f1c7869423a 33 fields · synced Jun 1, 2026