Identity
- Trade Name
- Pro-Fit Eco-Flex FDA UDI
- Generic Name
- Colonic lavage kit, non-surgical FDA UDI
- Device Name
- The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion stop disc, a water inflow tube and a collapsible waste hose. FDA UDI
- Model / Reference
- Small Kit with stop disc FDA UDI
- Description
- The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion stop disc, a water inflow tube and a collapsible waste hose. FDA UDI
Identifiers
- Catalog Number
- 8117-EF FDA UDI
- Primary DI / UDI-DI
- 07540198001111 FDA UDI
- FDA Product Code
- FFQ FDA UDI
- GMDN Term
- Colonic lavage kit, non-surgical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
No
FDA UDI
Category: Colonic lavage kit, non-surgical
Pro-Fit Eco-Flex by Prime Pacific Health Innovations Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Speculum, Rectal Kit — CLEARWATER COLON HYDROTHERAPY, INC. · Class I
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Prime Pacific Health Innovations Corporation
Sources (1)
- FDA UDI d0489473-34e2-443c-9170-7bc124dcdb8c 34 fields · synced Jun 6, 2026