Pacific West Medical

FDA UDI

Class II (US FDA UDI)

by Pacific West Medical, Inc.

Identity

Trade Name: Pacific West Medical FDA UDI
Generic Name: Electrode conductive skin pad, single-use FDA UDI
Device Name: The Pacific West Medical Adult/Child Radiotransparent Multi-Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on Adult/Child patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Philips Plug style connector models of monophasic and bi-phasic defibrillators. FDA UDI
Model / Reference: PWMC100-Philips FDA UDI
Description: The Pacific West Medical Adult/Child Radiotransparent Multi-Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on Adult/Child patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Philips Plug style connector models of monophasic and bi-phasic defibrillators. FDA UDI

Identifiers

Catalog Number: PWMC100-Philips FDA UDI
Primary DI / UDI-DI: 00852397008028 FDA UDI
510(k) Number: K080421 FDA UDI
FDA Product Code: MLN FDA UDI
GMDN Term: Electrode conductive skin pad, single-use 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

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: Electrode conductive skin pad, single-use

Pacific West Medical by Pacific West Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K080421 also covers:

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: Pacific West Medical, Inc.

Sources (1)

FDA UDI 27ce71b8-9298-4c86-8770-b597b2d8ba8c 37 fields · synced May 30, 2026