Identity
- Trade Name
- Trivarion FDA UDI
- Generic Name
- Drug-delivery iontophoresis patch FDA UDI
- Device Name
- Buffered Iontophoretic Delivery Kit- Butterfly, 2.0cc FDA UDI
- Model / Reference
- 001-60 FDA UDI
- Description
- Buffered Iontophoretic Delivery Kit- Butterfly, 2.0cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859975005073 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Drug-delivery iontophoresis patch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Drug-delivery iontophoresis patch
Trivarion by Activatek Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- IontoPatch — LTS Therapy Systems, LLC · Class II
- Ionto Plus Small 1.5 cc — COMPASS HEALTH BRANDS CORP. · Class II
- PERFORMA — Performance Health Supply, LLC · Class II
- Ionto Plus Butterfly — COMPASS HEALTH BRANDS CORP. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Activatek Inc.
Sources (1)
- FDA UDI b5daf83e-61ea-49bc-92ca-a322a31bae9a 33 fields · synced Jun 7, 2026