Duns Number:926938275
Device Description: The Pacific West Medical Adult/Child Radiotranslucent Multi-Function Electrodes are indica The Pacific West Medical Adult/Child Radiotranslucent 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 the 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). Comparable to Philips Plug Style connector models of monophasic and bi-phasic defibrillators.
Catalog Number
PWMT100-Philips
Brand Name
Pacific West Medical
Version/Model Number
PWMT100-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
K080421,K080421
Product Code
MLN
Product Code Name
Electrode, Electrodcardiograph, Multi-Function
Public Device Record Key
880fb03f-dd45-4108-96ae-1cb03033c88b
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 03, 2018
Package DI Number
00852397008011
Quantity per Package
10
Contains DI Package
00852397008004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case