DEVICE: Pro-Fit (07540198000305)
Device Identifier (DI) Information
Pro-Fit
Small Speculum Pack with stop disc
In Commercial Distribution
8114
Prime Pacific Health Innovations Corporation
Small Speculum Pack with stop disc
In Commercial Distribution
8114
Prime Pacific Health Innovations Corporation
The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion stop disc 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 | Rectal/colonic irrigation nozzle, single-use |
An invasive luminal device intended to be inserted into the rectum and/or colostomy site for the administration of irrigation fluid into the rectum and/or large intestines during a rectal irrigation, colonic lavage, enema, and/or colostomy site irrigation procedure. Available in a variety of designs, it may be referred to as a cone, tip, speculum, or rectal catheter, and may include an inflatable balloon for retention. This is a single-use device.
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Active | false |
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
cfce1043-6795-46c7-bd80-ac2489c911f4
June 19, 2024
5
September 30, 2016
June 19, 2024
5
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:
07540198000404
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined