DEVICE: Pro-Fit (07540198000381)

Device Identifier (DI) Information

Pro-Fit
Universal Speculum Pack
In Commercial Distribution
9126
Prime Pacific Health Innovations Corporation
07540198000381
GS1

10
250896255 *Terms of Use
The Pro-Fit Universal Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums to be used with compatible Colon Hydrotherapy Devices.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
FFQ Speculum, Rectal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9322b9f9-9f01-483e-beec-655de1c945b9
August 09, 2018
3
September 30, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 07540198000442 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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