DEVICE: Pro-Fit (07540198001241)
Device Identifier (DI) Information
Pro-Fit
Universal Kit
In Commercial Distribution
9125
Prime Pacific Health Innovations Corporation
Universal Kit
In Commercial Distribution
9125
Prime Pacific Health Innovations Corporation
The Pro-Fit Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a water inflow tube and a waste hose.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Colonic lavage kit, non-surgical | A collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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FFQ | Speculum, Rectal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bf3c7d68-e80c-4d69-9d77-7dc49db84c2b
October 22, 2018
3
September 23, 2016
October 22, 2018
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07540198001265 | 25 | 07540198001241 | In Commercial Distribution | Dispensing Bag | |
07540198001258 | 10 | 07540198001241 | In Commercial Distribution | Dispensing Bag |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined