FDA UDI
In Commercial Distribution
🇺🇸 United States
ActivaDose II
DI: 00859975005011
·
Model: 001-48
·
ACTIVATEK INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ActivaDose II
- Primary DI
- 00859975005011
- Version / Model
- 001-48
- Company Name
- ACTIVATEK INC.
- Labeler DUNS
- 790584176
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 26a16d73-2298-41c6-8c6b-ef5e8e11909f
Device Description
Iontophoresis Delivery Unit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | Physical Medicine | 890.5525 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46303 | Drug-delivery iontophoresis system generator | A battery-powered, portable device that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It supplies a constant direct current (e.g., 0.5 to 4 milliampere (mA) through a delivery electrode attached to the skin surface, and to which is typically attached a small reservoir containing a buffering agent and the medication (e.g., a corticosteroid or anaesthetic). A buffering agent return electrode completes the circuit. The reusable device typically includes setting controls and a display. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859975005011 | GS1 | ||||
| Package | 10859975005018 | GS1 | Case | 10 | In Commercial Distribution |