Premier Heart Reusable Limb Clip Electrodes

FDA UDI

Class II (US FDA UDI)

by Premier Heart, Llc

Identity

Trade Name: Premier Heart Reusable Limb Clip Electrodes FDA UDI
Generic Name: Electrocardiographic electrode, reusable FDA UDI
Device Name: Reusable Limb Clip Electrodes, Large, EU/IEC Lead Colors FDA UDI
Model / Reference: LCA2 FDA UDI
Description: Reusable Limb Clip Electrodes, Large, EU/IEC Lead Colors FDA UDI

Identifiers

Primary DI / UDI-DI: B320LCA20 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Electrocardiographic electrode, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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, reusable

Premier Heart Reusable Limb Clip Electrodes by Premier Heart, Llc — 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: Premier Heart, Llc

Sources (1)

FDA UDI c67b0136-fea2-47e4-94e8-0d54241c0e52 33 fields · synced May 30, 2026