Identity
- Trade Name
- Macroduct® Black Electrode Strap, Qty 1 FDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- For use with Macroduct Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis. FDA UDI
- Model / Reference
- RP-381 FDA UDI
- Description
- For use with Macroduct Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540300530 FDA UDI
- FDA Product Code
- KTB FDA UDI
- GMDN Term
- Sweat-induction iontophoresis system 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sweat-induction iontophoresis system
Macroduct® Black Electrode Strap, Qty 1 by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sweat-induction iontophoresis system.
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- Macroduct® Collector, Qty 1 — ELITECHGROUP INC. · Class II
- Macroduct® Sweat Collection System — ELITECHGROUP INC. · Class II
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- Macroduct® Pilogel Discs — ELITECHGROUP INC. · 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
- Elitechgroup Inc.
Sources (1)
- FDA UDI 7be73943-8230-47d5-b743-975c8b54e41c 34 fields · synced May 30, 2026