Pro-Fit Eco-Flex 8144-EF

GUDID 07540198001234

The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion guide rin

Prime Pacific Health Innovations Corporation

Colonic lavage kit, non-surgical
Primary Device ID07540198001234
NIH Device Record Key821ac46d-283d-46b0-8c80-a5f58167f46d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Fit Eco-Flex
Version Model NumberSmall Kit with guide rings
Catalog Number8144-EF
Company DUNS250896255
Company NamePrime Pacific Health Innovations Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540198001210 [Primary]
GS107540198001227 [Package]
Contains: 07540198001210
Package: Dispensing Bag [10 Units]
In Commercial Distribution
GS107540198001234 [Package]
Contains: 07540198001210
Package: Dispensing Bag [25 Units]
In Commercial Distribution

FDA Product Code

FFQSpeculum, Rectal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-22
Device Publish Date2016-09-23

On-Brand Devices [Pro-Fit Eco-Flex]

07540198001296The Pro-Fit Eco-Flex Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit co
07540198001234The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consis
07540198001180The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit cons
07540198001135The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consis
07540198001081The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit cons

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