Pacific West Medical

Primary DI
00852397008035
Brand
Pacific West Medical
Company
PACIFIC WEST MEDICAL, INC.
Model
PWMINFANT-Philips
Catalog number
PWMINFANT-Philips
Device 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.
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
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852397008042PackageGS110In Commercial Distribution
00852397008035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852397008042008523970080428523970080420852397008042
00852397008035008523970080358523970080350852397008035

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
00852397008028Pacific West MedicalPWMC100-PhilipsPWMC100-Philips2018-04-03

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