Trivarion

GUDID 00859975005066

Buffered Iontophoretic Delivery Kit- Large, 3.5cc

ACTIVATEK INC.

Drug-delivery iontophoresis patch

• Primary Device ID: 00859975005066
• NIH Device Record Key: a7aae02c-a675-41c3-a823-b05b3b0b8db0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trivarion
• Version Model Number: 001-35
• Company DUNS: 790584176
• Company Name: ACTIVATEK 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859975005066 [Primary]
GS1	10859975005063 [Package]; Package: Shelf Box [12 Units]; In Commercial Distribution
GS1	20859975005060 [Package]; Contains: 10859975005063; Package: Case [20 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-11-26

On-Brand Devices [Trivarion]

• 00859975005073: Buffered Iontophoretic Delivery Kit- Butterfly, 2.0cc
• 00859975005066: Buffered Iontophoretic Delivery Kit- Large, 3.5cc
• 00859975005059: Buffered Iontophoretic Delivery Kit- Medium, 2.0cc
• 00859975005042: Buffered Iontophoretic Delivery Kit- Small, 1.5cc