Identity
- Trade Name
- Colonic Irrigation Kit FDA UDI
- Generic Name
- Colonic lavage kit, non-surgical FDA UDI
- Device Name
- Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 921442 FDA UDI
- Model / Reference
- SP02 Small Straight 1442 FDA UDI
- Description
- Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 921442 FDA UDI
Identifiers
- Catalog Number
- 921442 FDA UDI
- Primary DI / UDI-DI
- B4249214420 FDA UDI
- 510(k) Number
- K000388 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Colonic lavage kit, non-surgical 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
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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Colonic lavage kit, non-surgical
Colonic Irrigation Kit by Clearwater Colon Hydrotherapy, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Colonic lavage kit, non-surgical.
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- Colonic Irrigation Kit — TRANSCENDENCIAS COMERCIALES SL · Class II
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Cleared under the same submission
K000388 also covers:
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC.
- Colonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC.
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
- Clearwater Colon Hydrotherapy, Inc.
Sources (1)
- FDA UDI 0275b321-b68c-49e3-b8fb-b4b821ad696d 37 fields · synced May 30, 2026