Identity
- Trade Name
- Macroduct® Advanced Electrode Cable Assembly FDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- For use with Macroduct Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis. FDA UDI
- Model / Reference
- RP-537 FDA UDI
- Description
- For use with Macroduct Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540300363 FDA UDI
- 510(k) Number
- K180627 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
- Not 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
Macroduct® Advanced Electrode Cable Assembly by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 f0c9d654-7634-4c9d-b981-fbd1e1fea1bf 36 fields · synced May 30, 2026