Ionto480 Buffered Iontophoresis Electrode Treatment Kit DDL350

GUDID 00856817005901

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 injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.

AXELGAARD MANUFACTURING CO., LTD.

Drug-delivery iontophoresis patch

• Primary Device ID: 00856817005901
• NIH Device Record Key: 91bb74b4-81e3-4143-a3ff-4a84c5772a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ionto480 Buffered Iontophoresis Electrode Treatment Kit
• Version Model Number: Ionto480 DDL350
• Catalog Number: DDL350
• Company DUNS: 150959401
• Company Name: AXELGAARD MANUFACTURING CO., LTD.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: support@axelgaard.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856817005901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080580

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-22

On-Brand Devices [Ionto480 Buffered Iontophoresis Electrode Treatment Kit]

• 00856817005918: A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-se
• 00856817005901: A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-se
• 00856817005895: A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-se
• 00856817005888: A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-se