Ionto Plus Small Electrode

Basic Information

• Brand Name: Ionto Plus Small Electrode
• Primary DI: 00092237901755
• Version / Model: 201-455
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 2
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: d680312f-1c09-4b34-8aa6-e5187f6d7081

Device Description

Iontophoresis Drug Delivery Small Kit Electrodes - 1.5cc, 3mA-minute, incl. buffered return 2.75" x 2.75"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	890.5525	2

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	80092237901751	GS1	Master Carton	24	In Commercial Distribution
Package	30092237901756	GS1	Inner Carton	12	In Commercial Distribution
Primary	00092237901755	GS1
Unit of Use	01092237901754	GS1

Customer Contacts

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