ActivaPatch IontoGo 12.0 NC89191

GUDID 10859975005223

ActivaPatch IontoGo 12.0 carton with 6 pouches, 12 hour iontophoresis delivery

ACTIVATEK INC.

Drug-delivery iontophoresis patch

• Primary Device ID: 10859975005223
• NIH Device Record Key: 3b8f9cdd-1b9f-4701-9d80-5a6ff7cca482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaPatch IontoGo 12.0
• Version Model Number: 001-90
• Catalog Number: NC89191
• Company DUNS: 790584176
• Company Name: ACTIVATEK INC.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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	00859975005028 [Unit of Use]
GS1	00859975005226 [Primary]
GS1	10859975005223 [Package]; Contains: 00859975005226; Package: Master Case [40 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: 2016-06-14

Devices Manufactured by ACTIVATEK INC.

• 00859975005011 - ActivaDose II: 2018-03-29 Iontophoresis Delivery Unit
• 00859975005042 - Trivarion: 2018-03-29 Buffered Iontophoretic Delivery Kit- Small, 1.5cc
• 00859975005059 - Trivarion: 2018-03-29 Buffered Iontophoretic Delivery Kit- Medium, 2.0cc
• 00859975005066 - Trivarion: 2018-03-29 Buffered Iontophoretic Delivery Kit- Large, 3.5cc
• 00859975005073 - Trivarion: 2018-03-29 Buffered Iontophoretic Delivery Kit- Butterfly, 2.0cc
• 00859975005080 - Trivarion Medium & Butterfly Sample: 2018-03-29 Trivarion Buffered Iontophoretic Delivery Kit- Medium (1) and Butterfly (1) Sample Pack
• 00859975005097 - ActivaPatch IontoGo 4.0 Sample: 2018-03-29 ActivaPatch IontoGo 4.0 Sample Pack (2)
• 00859975005103 - ActivaPatch IontoGo 12.0 Sample: 2018-03-29 ActivaPatch IontoGo 12.0 Sample Pack (2)