Meridian Disposable fECG Electrode Patch

FDA UDI

Class II (US FDA UDI)

by Mindchild Medical

Identity

Trade Name: Meridian Disposable fECG Electrode Patch FDA UDI
Generic Name: Electrocardiographic electrode, single-use FDA UDI
Device Name: The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides, which provides continuous fetal signal capture during fetal movement. FDA UDI
Model / Reference: MDPA1 FDA UDI
Description: The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides, which provides continuous fetal signal capture during fetal movement. FDA UDI

Identifiers

Primary DI / UDI-DI: 00867696000321 FDA UDI
FDA Product Code: HGM FDA UDI
GMDN Term: Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.2740 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiographic electrode, single-use

Meridian Disposable fECG Electrode Patch by Mindchild Medical — 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: Mindchild Medical

Sources (1)

FDA UDI e2ee1fd5-1228-4b48-a3c7-f8379bf80882 33 fields · synced May 30, 2026