Identity
- Trade Name
- Macroduct® Advanced Supply Kit, Qty 6 FDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis. FDA UDI
- Model / Reference
- SS-268 FDA UDI
- Description
- For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540304378 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
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sweat-induction iontophoresis system
Macroduct® Advanced Supply Kit, Qty 6 by Elitechgroup Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Sweat-induction iontophoresis system.
- Q-Sweat — WR Medical Electronics Co. · Class II
- Macroduct® Collection Strap, Large, Qty 1 — ELITECHGROUP INC. · Class II
- Macroduct® Advanced Supply Kit, w/o Dye, Qty 6 — ELITECHGROUP INC. · Class II
- Macroduct® Collection Strap, XLarge, Qty 1 — ELITECHGROUP INC. · Class II
- Macroduct® Collector, Qty 1 — ELITECHGROUP INC. · Class II
- Macroduct® Sweat Collection System — ELITECHGROUP INC. · Class II
- Macroduct® Collection Strap, Small, Qty 1 — ELITECHGROUP INC. · Class II
- Macroduct® Black Electrode Strap, Qty 1 — ELITECHGROUP INC. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Elitechgroup Inc.
Sources (2)
- FDA UDI 4e1f8cf7-efb4-4166-ada3-ffc0e68b8feb 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026