Pro-Fit Eco-Flex 8116-EF

GUDID 07540198001081

Colonic lavage kit, non-surgical

Primary Device ID	07540198001081
NIH Device Record Key	2f203f5f-5828-4a53-a786-3d74dab5d151
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pro-Fit Eco-Flex
Version Model Number	Regular Kit with stop disc
Catalog Number	8116-EF
Company DUNS	250896255
Company Name	Prime Pacific Health Innovations Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07540198001067 [Primary]
GS1	07540198001074 [Package] Contains: 07540198001067 Package: Dispensing Bag [10 Units] In Commercial Distribution
GS1	07540198001081 [Package] Contains: 07540198001067 Package: Dispensing Bag [25 Units] In Commercial Distribution

FFQ	Speculum, Rectal

Steralize Prior To Use	false
Device Is Sterile	false

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