DEVICE: Pro-Fit (07540198000381)
Device Identifier (DI) Information
Pro-Fit
Universal Speculum Pack
In Commercial Distribution
9126
Prime Pacific Health Innovations Corporation
Universal Speculum Pack
In Commercial Distribution
9126
Prime Pacific Health Innovations Corporation
The Pro-Fit Universal Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums to be used with compatible Colon Hydrotherapy Devices.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Colonic lavage nozzle, non-sterile, single-use | A non-sterile, hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system/unit; it may additionally be intended for use with an enema kit for the delivery of an enema solution. It is typically designed as a one-piece, moulded nozzle that may have a bulb shape at the distal end to improve retention in the rectum and a barbed fitting at the proximal end for the attachment of the irrigation/enema tubing. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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
9322b9f9-9f01-483e-beec-655de1c945b9
August 09, 2018
3
September 30, 2016
August 09, 2018
3
September 30, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
07540198000442
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined