AccessGUDID - DEVICE: Pro-Fit (07540198000381)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Fit
Version or Model: Universal Speculum Pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9126
Company Name: Prime Pacific Health Innovations Corporation

Primary DI Number: 07540198000381
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 250896255 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

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Product Code	Product Code Name
FFQ	Speculum, Rectal

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9322b9f9-9f01-483e-beec-655de1c945b9
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2016