Pro Advantage Buffered Iontophoresis Electrode Treatment Kit

Basic Information

• Brand Name: Pro Advantage Buffered Iontophoresis Electrode Treatment Kit
• Primary DI: M220P8503252
• Version / Model: P850325
• Catalog Number: P850325
• Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.
• Labeler DUNS: 009831413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f5b5f853-989f-456b-b0e1-106c27b7623e

Device Description

Gentle Stim Ionto Buffered Iontophoresis Electrode Treatment Kit Latex fee, Non-Sterile disposable single use only medium square

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
45141	Drug-delivery iontophoresis patch	A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M220P8503255	HIBCC	Bag	10
Primary	M220P8503252	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 41 – 80.6 Degrees Fahrenheit