DEVICE: Pro-Fit (07540198000343)
Device Identifier (DI) Information
Pro-Fit
Small Speculum Pack with guide rings
In Commercial Distribution
8141
Prime Pacific Health Innovations Corporation
Small Speculum Pack with guide rings
In Commercial Distribution
8141
Prime Pacific Health Innovations Corporation
The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
14187 | Colonic lavage nozzle, single-use |
A 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.
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Active | false |
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
542010b5-a0ee-49b0-b226-3023246704fe
December 22, 2023
6
September 30, 2016
December 22, 2023
6
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:
07540198000428
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined