Identity
- Trade Name
- Colonic Irrigation Nozzle FDA UDI
- Generic Name
- Rectal/colonic irrigation nozzle, single-use FDA UDI
- Device Name
- Large Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 720400 FDA UDI
- Model / Reference
- SP01 Large Bulb Speculum FDA UDI
- Description
- Large Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 720400 FDA UDI
Identifiers
- Catalog Number
- 720400 FDA UDI
- Primary DI / UDI-DI
- B4247204000 FDA UDI
- 510(k) Number
- K000388 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Rectal/colonic irrigation nozzle, single-use 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rectal/colonic irrigation nozzle, single-use
Colonic Irrigation Nozzle by Clearwater Colon Hydrotherapy, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal/colonic irrigation nozzle, single-use.
- Bard® Colon Tubes — C. R. Bard, Inc. · Class II
- Bard® Colon Tubes — C. R. Bard, Inc. · Class II
- Bard® Rectal Tubes — C. R. Bard, Inc. · Class II
- Pro-Fit — Prime Pacific Health Innovations Corporation · Class I
- Bard® Rectal Tubes — C. R. Bard, Inc. · Class II
- Pro-Fit — Prime Pacific Health Innovations Corporation · Class I
- Bard® Colon Tubes — C. R. Bard, Inc. · Class II
- Bard® Colon Tubes — C. R. Bard, Inc. · Class II
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 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.
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 806bb15e-c348-4493-ae06-18d6e5235e8f 37 fields · synced May 29, 2026