FDA.reportPublic FDA data

Aquanet

Primary DI
07540198000121
Brand
Aquanet
Company
Prime Pacific Health Innovations Corporation
Model
GRY-500
Catalog number
4300
Device description
The Aquanet GRY-500 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K000031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000031000AQUANET, MODEL EC 2000Prime Pacific Health Innovations Corporation2001-09-10KPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540198000121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540198000121075401980001217540198000121

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage system, gravity-flowAn assembly of devices designed for the irrigation, washing, and evacuation of debris from the colon. It typically consists of a fluid reservoir, tubing, nozzle, and controls that regulate the temperature and pressure of the gravity-induced water flow from a tap (faucet) and into the rectum. The device may include a console-type toilet and fittings to allow connection to water and sewer pipes for the effluent. The system provides colonic hydrotherapy to remove damaged tissue and/or debris (e.g., faeces, foreign objects) in emergency departments, and to clean/evacuate the colon for endoscopic/surgical procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250896255
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540198001005Pro-FitRegular Kit with stop disc81162016-09-23
07540198001012Pro-FitSmall Kit with stop disc81172016-09-23
07540198001029Pro-FitRegular Kit with guide rings81432016-09-23
07540198001036Pro-FitSmall Kit with guide rings81442016-09-23
07540198001067Pro-Fit Eco-FlexRegular Kit with stop disc8116-EF2016-09-23
07540198001111Pro-Fit Eco-FlexSmall Kit with stop disc8117-EF2016-09-23
07540198001166Pro-Fit Eco-FlexRegular Kit with guide rings8143-EF2016-09-23
07540198001210Pro-Fit Eco-FlexSmall Kit with guide rings8144-EF2016-09-23
07540198001241Pro-FitUniversal Kit91252016-09-23
07540198001272Pro-Fit Eco-FlexUniversal Kit9125-EF2016-09-23
07540198000305Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000312Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000329Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000336Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000343Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000350Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000367Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000374Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000381Pro-FitUniversal Speculum Pack91262016-09-30
07540198000398Pro-FitUniversal Speculum Pack91262016-09-30

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