FDA.reportPublic FDA data

Colonic lavage kit, non-surgical

Definition
A 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.
GUDID devices
85
Last updated
2026-08-01 06:05:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850048720619Speculum KitsSpecialty Health Products, LLC12042026-07-23
00850048720626Speculum KitsSpecialty Health Products, LLC13042026-07-23
00850048720633Speculum KitsSpecialty Health Products, LLC1104-C2026-07-23
00850048720640Speculum KitsSpecialty Health Products, LLC1304-C2026-07-23
00850048720732Speculum KitsSpecialty Health Products, LLC1204-C2026-07-23
00850048720541Speculum KitsSpecialty Health Products, LLC11042026-07-22
00850014947002QMS - 48SBSTQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947019QMS - 48CFSTQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947026QMS - 48SBSPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947033QMS - 48CFSPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947040QMS - 48SBOPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947057QMS - 48CFOPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947064QMS - 48SBHYQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947071QMS - 48CFHYQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947088QMS - 42SBSTQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947095QMS - 42CFSTQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947101QMS - 42SBSPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947118QMS - 42CFSPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947125QMS - 42SBOPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947132QMS - 42CFOPQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947149QMS - 42SBHYQUALITY MEDICAL SUPPLY, INC.012019-12-12
00850014947156QMS - 42CFHYQUALITY MEDICAL SUPPLY, INC.012019-12-12
07540198001005Pro-FitPrime Pacific Health Innovations CorporationRegular Kit with stop disc2016-09-23
07540198001012Pro-FitPrime Pacific Health Innovations CorporationSmall Kit with stop disc2016-09-23
07540198001029Pro-FitPrime Pacific Health Innovations CorporationRegular Kit with guide rings2016-09-23
07540198001036Pro-FitPrime Pacific Health Innovations CorporationSmall Kit with guide rings2016-09-23
07540198001067Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationRegular Kit with stop disc2016-09-23
07540198001111Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationSmall Kit with stop disc2016-09-23
07540198001166Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationRegular Kit with guide rings2016-09-23
07540198001210Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationSmall Kit with guide rings2016-09-23
07540198001241Pro-FitPrime Pacific Health Innovations CorporationUniversal Kit2016-09-23
07540198001272Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationUniversal Kit2016-09-23
B424720100C1Speculum, RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Straight Speculum2017-09-05
B424720200C1Speculum, RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Bulb Speculum2017-09-05
B424720300C1Speculum RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Straight Speculum2017-09-05
B424720400C1Speculum, RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Bulb Speculum 2017-09-05
B4249214420Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Straight 14422016-09-24
B4249214480Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Straight 14482016-09-24
B4249224420Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Bulb 14422016-09-24
B4249224480Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Bulb 14482016-09-24
B424922648Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Bulb 3848 G-Hose2017-09-05
B4249234420Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Straight 14422016-09-24
B4249234480Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Straight 14482016-09-24
B4249244420Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Bulb 14422016-09-24
B4249244480Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Bulb 14482016-09-24
B482Z090Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLLarge Hydrokit2016-12-29
B482Z100Colonic irrigation KitTRANSCENDENCIAS COMERCIALES SLSmall Hydrokit2016-12-29
B482Z160Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLSegmented Hose / Hydrokit with limiter2016-12-29
B482Z170Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLHydrokit with limiter2016-12-29
B482Z200Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLSegmented Hose / Large Hydrokit2016-12-29
B4247201000C1Speculum, RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Straight Speculum2017-09-05
B4247202000C1Speculum, RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Bulb Speculum2017-09-05
B4247203000C1Speculum RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Straight Speculum2017-09-05
B4247204000C1Speculum, RectalCLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Bulb Speculum 2017-09-05
B424921442Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Straight 14422016-09-24
B424921448Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Straight 14482016-09-24
B424921478C1Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Straight 1448 G-Hose2017-09-05
B424921648Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Straight 3848 G-Hose2017-09-05
B424922442Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Bulb 14422016-09-24
B424922448Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP02 Small Bulb 14482016-09-24
B424922478C1Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Bulb 1448 G-Hose2017-09-05
B4249226480Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO2 Small Bulb 3848 G-Hose2017-09-05
B424923442Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Straight 14422016-09-24
B424923448Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Straight 14482016-09-24
B424923478C1Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Straight 1448 G-Hose2017-09-05
B424923648Speculum, Rectal Kit CLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Straight 3848 G-Hose2017-09-05
B424924442Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Bulb 14422016-09-24
B424924448Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Bulb 14482016-09-24
B424924478C1Speculum, Rectal Kit CLEARWATER COLON HYDROTHERAPY, INC.SP01 Large Bulb 1448 G-Hose2017-09-05
B424924648Speculum, Rectal KitCLEARWATER COLON HYDROTHERAPY, INC.SPO1 Large Bulb 3848 G-Hose2017-09-05
B482Z091Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLLarge Hydrokit2016-12-29
B482Z101Colonic irrigation KitTRANSCENDENCIAS COMERCIALES SLSmall Hydrokit2016-12-29
B482Z161Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLSegmented Hose / Hydrokit with limiter2016-12-29
B482Z171Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLHydrokit with limiter2016-12-29
B482Z201Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLSegmented Hose / Large Hydrokit2016-12-29
07540198001050Pro-FitPrime Pacific Health Innovations CorporationRegular Kit with stop disc2016-09-23
07540198001081Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationRegular Kit with stop disc2016-09-23
07540198001104Pro-FitPrime Pacific Health Innovations CorporationSmall Kit with stop disc2016-09-23
07540198001135Pro-Fit Eco-FlexPrime Pacific Health Innovations CorporationSmall Kit with stop disc2016-09-23
07540198001159Pro-FitPrime Pacific Health Innovations CorporationRegular Kit with guide rings2016-09-23