FDA.reportPublic FDA data

Pro-Fit

Primary DI
07540198001029
Brand
Pro-Fit
Company
Prime Pacific Health Innovations Corporation
Model
Regular Kit with guide rings
Catalog number
8143
Device description
The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide rings, a water inflow tube and a waste hose.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07540198001142PackageGS110In Commercial Distribution
07540198001159PackageGS125In Commercial Distribution
07540198001340PackageGS150In Commercial Distribution
07540198001029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540198001142075401980011427540198001142
07540198001159075401980011597540198001159
07540198001340075401980013407540198001340
07540198001029075401980010297540198001029

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.

Regulatory Flags#

DUNS number
250896255
Device count
1
Kit
true
Lot or batch
true

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
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
07540198000107AquanetAPS-10043052016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055445961398SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961404SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961411SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12