FDA.reportPublic FDA data

Colonic Irrigation Kit

Primary DI
B4249244420
Brand
Colonic Irrigation Kit
Company
CLEARWATER COLON HYDROTHERAPY, INC.
Model
SP01 Large Bulb 1442
Catalog number
924442
Device description
Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 924442
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPLColonic Irrigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPLColonic Irrigation SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000388000CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)Clearwater Colon Hydrotherapy, Inc.2000-08-08KPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B424924442PackageHIBCC1In Commercial Distribution
B4249244420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage kit, non-surgicalA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stored in Room Temperature

Contacts#

Phone, Email table
PhoneEmail
352-401-0303sales@colonhydrotheray.com

Regulatory Flags#

DUNS number
942667882
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B4247201000Colonic Irrigation NozzleSP02 Small Straight Speculum7201002016-09-24
B4247202000Colonic Irrigation NozzleSP02 Small Bulb Speculum7202002016-09-24
B4247203000Colonic Irrigation NozzleSP01 Large Straight Speculum7203002016-09-24
B4247204000Colonic Irrigation NozzleSP01 Large Bulb Speculum 7204002016-09-24
B424720100C1Speculum, RectalSPO2 Small Straight Speculum720100C12017-09-05
B424720200C1Speculum, RectalSPO2 Small Bulb Speculum720200C12017-09-05
B424720300C1Speculum RectalSPO1 Large Straight Speculum720300C12017-09-05
B424720400C1Speculum, RectalSPO1 Large Bulb Speculum 720400C12017-09-05
B4249214420Colonic Irrigation KitSP02 Small Straight 14429214422016-09-24
B4249214480Colonic Irrigation KitSP02 Small Straight 14489214482016-09-24
B4249224420Colonic Irrigation KitSP02 Small Bulb 14429224422016-09-24
B4249224480Colonic Irrigation KitSP02 Small Bulb 14489224482016-09-24
B424922648Speculum, Rectal KitSPO2 Small Bulb 3848 G-Hose9226482017-09-05
B4249234420Colonic Irrigation KitSP01 Large Straight 14429234422016-09-24
B4249234480Colonic Irrigation KitSP01 Large Straight 14489234482016-09-24
B4249244480Colonic Irrigation KitSP01 Large Bulb 14489244482016-09-24
B4247201000C1Speculum, RectalSPO2 Small Straight Speculum720100C12017-09-05
B4247202000C1Speculum, RectalSPO2 Small Bulb Speculum720200C12017-09-05
B4247203000C1Speculum RectalSPO1 Large Straight Speculum720300C12017-09-05
B4247204000C1Speculum, RectalSPO1 Large Bulb Speculum 720400C12017-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B149CM11Angel of WaterLIFESTREAM PURIFICATION SYSTEM LLCKPL2023-12-11
00868538000417LIBBE Colonic NozzleMind Body Naturopathic InstKPL2021-04-30
10868538000414LIBBE Colonic NozzleMind Body Naturopathic InstKPL2021-04-30
00850014947163QMS - AQUA CLEANSEQUALITY MEDICAL SUPPLY, INC.KPL2019-12-12
00868538000400LIBBE Colon Hydrotherapy SystemMind Body Naturopathic InstKPL2017-12-29
B149SP0001Colon Cleansing Nozzle with Flex TubeLIFESTREAM PURIFICATION SYSTEM LLCKPL2017-02-10
B149SP00011Colon Cleansing Nozzle with Flex TubeLIFESTREAM PURIFICATION SYSTEM LLCKPL2017-02-10
B482HC10Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC1C0Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC2000C0Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z090Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z100Colonic irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z160Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z170Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z200Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC11Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC1C1Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC2000C1Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z091Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z101Colonic irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z161Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z171Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z201Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B4244001010Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4244001510Colonic Lavage SystemCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4244002010Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247201000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247202000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247203000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247204000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24