Identity
- Trade Name
- Colonic Lavage Unit FDA UDI
- Generic Name
- Colonic lavage unit FDA UDI
- Device Name
- Colonic Hydroteraphy machine designed for semi-automatic irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a wall fixed, non-portable machine. FDA UDI
- Model / Reference
- HC-2000 Classic FDA UDI
- Description
- Colonic Hydroteraphy machine designed for semi-automatic irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a wall fixed, non-portable machine. FDA UDI
Identifiers
- Catalog Number
- HC-2000 Classic FDA UDI
- Primary DI / UDI-DI
- B482HC2000C0 FDA UDI
- 510(k) Number
- K970482 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Colonic lavage unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5220 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colonic lavage unit
Colonic Lavage Unit by Transcendencias Comerciales Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SL · 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
- Transcendencias Comerciales Sl
Sources (1)
- FDA UDI 3f1f6616-9fea-4c0b-a6f0-4ceaa00aa496 35 fields · synced May 30, 2026