IontoPatch

GUDID 10815611020029

The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis.

TAPEMARK COMPANY, THE

Drug-delivery iontophoresis patch

• Primary Device ID: 10815611020029
• NIH Device Record Key: bc4afcdd-324a-4395-a882-e52736522434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IontoPatch
• Version Model Number: SP
• Company DUNS: 006154595
• Company Name: TAPEMARK COMPANY, THE
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com
• Phone: 612-245-7088
• Email: mezzettj@tapemark.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815611020029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992708

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: 4
• Public Version Date: 2020-10-30
• Device Publish Date: 2016-10-03

On-Brand Devices [IontoPatch]

• 10815611020036: The IontoPatch contains an innovative self-contained battery that produces an electric current t
• 10815611020029: The IontoPatch contains an innovative self-contained battery that produces an electric current t
• 10815611020012: The IontoPatch contains an innovative self-contained battery that produces an electric current t
• 10815611020005: The IontoPatch contains an innovative self-contained battery that produces an electric current t