FDA.reportPublic FDA data

Pacific West Medical

Primary DI
00852397008028
Brand
Pacific West Medical
Company
PACIFIC WEST MEDICAL, INC.
Model
PWMC100-Philips
Catalog number
PWMC100-Philips
Device 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.
Published
2018-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLNElectrode, Electrodcardiograph, Multi-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080421000HEART SYNC, MODELS C-100 AND T-100Heart Sync, LLC2008-02-29MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852397008059PackageGS110In Commercial Distribution
00852397008028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852397008059008523970080598523970080590852397008059
00852397008028008523970080288523970080280852397008028

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode padA conductive medium designed to be used between the metal contact surface of an external defibrillator electrode, of the paddle-type, and the patient's skin. A defibrillator electrode pad is available in two basic designs: 1) a thickened conductive gel or polymer layer reinforced by a non-woven material; or 2) a conductive adhesive pad with a metal contact on its outer surface. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)705-3256scott@pacificwestmedical.com

Regulatory Flags#

DUNS number
926938275
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852397008004Pacific West MedicalPWMT100-PhilipsPWMT100-Philips2018-04-03
00852397008035Pacific West MedicalPWMINFANT-PhilipsPWMINFANT-Philips2018-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838126275PHILIPS HeartStart SMARTPADS IIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMLN2026-08-26
00009336010080Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
00009336010097Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010085Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010092Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
10888277634893MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634909MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634961MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634985MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634992MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635005MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635012MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635029MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635036MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635050MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635067MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635074MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635081MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635098MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635104MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105463Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105555Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
10326053105453Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105460Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105477Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105552Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
00009336009497Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009503Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17