FDA.reportPublic FDA data

Pro-Fit

Primary DI
07540198000329
Brand
Pro-Fit
Company
Prime Pacific Health Innovations Corporation
Model
Regular Speculum Pack with stop disc
Catalog number
8115
Device description
The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.
Published
2016-09-30
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
07540198000329PrimaryGS10
07540198000411Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540198000329075401980003297540198000329
07540198000411075401980004117540198000411

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage nozzle, non-sterile, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250896255
Device count
10
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
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
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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