Identity
- Trade Name
- Pro-Fit FDA UDI
- Generic Name
- Rectal/colonic irrigation nozzle, single-use FDA UDI
- Device Name
- The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices. FDA UDI
- Model / Reference
- Regular Speculum Pack with stop disc FDA UDI
- Description
- The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices. FDA UDI
Identifiers
- Catalog Number
- 8115 FDA UDI
- Primary DI / UDI-DI
- 07540198000336 FDA UDI
- FDA Product Code
- FFQ FDA UDI
- GMDN Term
- Rectal/colonic irrigation nozzle, single-use 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
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
No
FDA UDI
Category: Rectal/colonic irrigation nozzle, single-use
Pro-Fit by Prime Pacific Health Innovations Corporation — Class I — 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
- Bard® Rectal Tubes — C. R. Bard, Inc. · Class II
- Colonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
- 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
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 4e00f720-babb-456d-9c07-e741eeec1113 34 fields · synced May 30, 2026