Identity
- Trade Name
- BodyMed FDA UDI
- Generic Name
- Drug-delivery iontophoresis patch FDA UDI
- Device Name
- BODYMED IONTOPHORESIS, ELECTRODES BUTTERFLY 3.75" X 3.75", 12/BOX FDA UDI
- Model / Reference
- ZZAI375B FDA UDI
- Description
- BODYMED IONTOPHORESIS, ELECTRODES BUTTERFLY 3.75" X 3.75", 12/BOX FDA UDI
Identifiers
- Catalog Number
- ZZAI375B FDA UDI
- Primary DI / UDI-DI
- 00815991022081 FDA UDI
- 510(k) Number
- K080580 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Drug-delivery iontophoresis patch
BodyMed by Boxout, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Drug-delivery iontophoresis patch.
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- Trivarion — ACTIVATEK INC. · Class II
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Cleared under the same submission
K080580 also covers:
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- BodyMed — BOXOUT, LLC
- BodyMed — BOXOUT, LLC
- BodyMed — BOXOUT, LLC
- PERFORMA — Performance Health Supply, LLC
- PERFORMA — Performance Health Supply, LLC
- PERFORMA — Performance Health Supply, LLC
- PERFORMA — Performance Health Supply, LLC
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
- Boxout, Llc
Sources (1)
- FDA UDI e1dc4f5b-065a-4474-8faa-39f4ecee3896 36 fields · synced May 30, 2026