MR Patient Care Single Patch ECG Electrodes (25)

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name: MR Patient Care Single Patch ECG Electrodes (25) FDA UDI
Generic Name: Electrocardiographic electrode, single-use FDA UDI
Model / Reference: QUADTRODE MRI ECG PAD,25/BOX FDA UDI

Identifiers

Catalog Number: 989803179031 FDA UDI
Primary DI / UDI-DI: 20884838029525 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiographic electrode, single-use

MR Patient Care Single Patch ECG Electrodes (25) by Philips DS North America 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: Philips DS North America LLC

Sources (1)

FDA UDI 4a55c2ee-251e-43e8-bd98-4611f788fe59 34 fields · synced Jun 8, 2026