AccessGUDID - DEVICE: Pro-Fit (07540198000305)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Fit
Version or Model: Small Speculum Pack with stop disc
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8114
Company Name: Prime Pacific Health Innovations Corporation

Primary DI Number: 07540198000305
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 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

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

[?]

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.	Active	false

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cfce1043-6795-46c7-bd80-ac2489c911f4
Public Version Date: June 19, 2024
Public Version Number: 5
DI Record Publish Date: September 30, 2016