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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 Pediatric (Infant) Radiotranslucent Multifunction 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 the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (100 joules). 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 manual defibrillators whose output is classified as low power (360 joule maximum), and not for AED use. The defibrillator needs to be manually adjusted to 100 joules or lower depending on the actual weight of patient. Comparable with Philips Plug Style connector models of monophasic and bi-phasic defibrillators. FDA UDI
Model / Reference
PWMINFANT-Philips FDA UDI
Description
The Pacific West Pediatric (Infant) Radiotranslucent Multifunction 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 the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (100 joules). 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 manual defibrillators whose output is classified as low power (360 joule maximum), and not for AED use. The defibrillator needs to be manually adjusted to 100 joules or lower depending on the actual weight of patient. Comparable with Philips Plug Style connector models of monophasic and bi-phasic defibrillators. FDA UDI

Identifiers

Catalog Number
PWMINFANT-Philips FDA UDI
Primary DI / UDI-DI
00852397008035 FDA UDI
FDA Product Code
LDD FDA UDI
GMDN Term
Electrode conductive skin pad, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Electrode conductive skin pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pacific West Medical, Inc.

Sources (1)

  • FDA UDI 71f79ac0-6712-4487-ba7e-36790c3cf358 36 fields · synced Jun 8, 2026