Pacific West Medical PWMC100-Philips

GUDID 00852397008028

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.

PACIFIC WEST MEDICAL, INC.

External defibrillator electrode pad

• Primary Device ID: 00852397008028
• NIH Device Record Key: 27ce71b8-9298-4c86-8770-b597b2d8ba8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pacific West Medical
• Version Model Number: PWMC100-Philips
• Catalog Number: PWMC100-Philips
• Company DUNS: 926938275
• Company Name: PACIFIC WEST MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com
• Phone: (800)705-3256
• Email: scott@pacificwestmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852397008028 [Primary]
GS1	00852397008059 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080421

FDA Product Code

• MLN: Electrode, Electrodcardiograph, Multi-Function

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-03

On-Brand Devices [Pacific West Medical]

• 00852397008035: The Pacific West Pediatric (Infant) Radiotranslucent Multifunction Electrodes are indicated for
• 00852397008028: The Pacific West Medical Adult/Child Radiotransparent Multi-Function Electrodes are indicated fo
• 00852397008004: The Pacific West Medical Adult/Child Radiotranslucent Multi-Function Electrodes are indicated fo