Duns Number:926938275
Device Description: The Pacific West Pediatric (Infant) Radiotranslucent Multifunction Electrodes are indicate 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.
Catalog Number
PWMINFANT-Philips
Brand Name
Pacific West Medical
Version/Model Number
PWMINFANT-Philips
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LDD
Product Code Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Public Device Record Key
71f79ac0-6712-4487-ba7e-36790c3cf358
Public Version Date
May 04, 2018
Public Version Number
1
DI Record Publish Date
April 03, 2018
Package DI Number
00852397008042
Quantity per Package
10
Contains DI Package
00852397008035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case