ActivaPatch NC89188

GUDID 00859975005219

IntelliDose, 2.5 hour iontophoresis delivery

ACTIVATEK INC.

Drug-delivery iontophoresis patch

• Primary Device ID: 00859975005219
• NIH Device Record Key: 031e3514-efad-4ee3-b524-f9d5345d842a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaPatch
• Version Model Number: 001-40
• Catalog Number: NC89188
• 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	00859975005004 [Unit of Use]
GS1	00859975005219 [Primary]
GS1	10859975005216 [Package]; Package: Master Carton [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: 2016-08-22

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)