Identity
- Trade Name
- LIBBE Colonic Nozzle FDA UDI
- Generic Name
- Colonic lavage nozzle, sterile FDA UDI
- Device Name
- One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicated, such as before radiological or endoscopic examination. FDA UDI
- Model / Reference
- 298-8888 FDA UDI
- Description
- One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicated, such as before radiological or endoscopic examination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868538000417 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Colonic lavage nozzle, sterile 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colonic lavage nozzle, sterile
LIBBE Colonic Nozzle by Mind Body Naturopathic Inst — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colonic lavage nozzle, sterile.
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
- Mind Body Naturopathic Inst
Sources (1)
- FDA UDI 515c8cb9-faaf-49e6-8c03-dc57ddedaf24 34 fields · synced May 30, 2026