Prime Pacific Health Innovations Corporation

Address:1132 - 585 Seaborne Avenue,PORT COQUITLAM British Columbia,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Speculum, Rectal (FFQ) (3)

Premarket Exempt

Clear

Pro-Fit Eco-Flex - 07540198001210 Catalog Number : 8144-EF

Device Description : The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Spe 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 rings, a water inflow tube and a collapsible waste hose.

Device Class :

Duns Number: 250896255

Premarket Exempt : No

Product Code : FFQ

Prescription Use : Yes

Device Count : 1

Pro-Fit - 07540198001241 Catalog Number : 9125

Device Description : The Pro-Fit Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum The Pro-Fit Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a water inflow tube and a waste hose.

Device Class :

Duns Number: 250896255

Premarket Exempt : No

Product Code : FFQ

Prescription Use : Yes

Device Count : 1

Pro-Fit Eco-Flex - 07540198001272 Catalog Number : 9125-EF

Device Description : The Pro-Fit Eco-Flex Universal Kit is a Colon Hydrotherapy Disposable Single-Use The Pro-Fit Eco-Flex Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a water inflow tube and a collapsible waste hose.

Device Class :

Duns Number: 250896255

Premarket Exempt : No

Product Code : FFQ

Prescription Use : Yes

Device Count : 1

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