FDA.reportPublic FDA data

Pro-Fit

Primary DI
07540198001203
Brand
Pro-Fit
Company
Prime Pacific Health Innovations Corporation
Model
Small Kit with guide rings
Catalog number
8144
Device description
The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion guide rings, a wat
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FFQSpeculum, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540198001197PackageGS110In Commercial Distribution
07540198001203PackageGS125In Commercial Distribution
07540198001364PackageGS150In Commercial Distribution
07540198001036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540198001197075401980011977540198001197
07540198001203075401980012037540198001203
07540198001364075401980013647540198001364
07540198001036075401980010367540198001036

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage kit, non-surgicalA collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250896255
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540198001005Pro-FitRegular Kit with stop disc81162016-09-23
07540198001012Pro-FitSmall Kit with stop disc81172016-09-23
07540198001029Pro-FitRegular Kit with guide rings81432016-09-23
07540198001036Pro-FitSmall Kit with guide rings81442016-09-23
07540198001067Pro-Fit Eco-FlexRegular Kit with stop disc8116-EF2016-09-23
07540198001111Pro-Fit Eco-FlexSmall Kit with stop disc8117-EF2016-09-23
07540198001166Pro-Fit Eco-FlexRegular Kit with guide rings8143-EF2016-09-23
07540198001210Pro-Fit Eco-FlexSmall Kit with guide rings8144-EF2016-09-23
07540198001241Pro-FitUniversal Kit91252016-09-23
07540198001272Pro-Fit Eco-FlexUniversal Kit9125-EF2016-09-23
07540198000305Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000312Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000329Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000336Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000343Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000350Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000367Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000374Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000381Pro-FitUniversal Speculum Pack91262016-09-30
07540198000398Pro-FitUniversal Speculum Pack91262016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432362MillenniumAvalign Technologies, Inc.FFQ2026-09-24
00860015748508Thermora AnoscopeOMEC Medical (NV) Inc.FFQ2026-07-31
00190776422189MillenniumAvalign Technologies, Inc.FFQ2026-07-28
00850048720619Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720626Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720633Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720640Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720732Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720541Speculum KitsSpecialty Health Products, LLCFFQ2026-07-22
05055445961107SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
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05055445961312SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
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