Colonic Lavage System

Primary DI
B4244002010
Brand
Colonic Lavage System
Company
CLEARWATER COLON HYDROTHERAPY, INC.
Model
PPC-101 Traveler
Catalog number
400201
Device description
PPC-101 The Traveler UV (Built In Ultra-Violet with 4 filter system) With Carrying CaseCCH Part No. 400201
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K942867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942867000CLEARWATER COLON HYDROTHERAPY MODEL PPC-101Clearwater Colon Hydrotherapy, Inc.1996-06-26KPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B424400200PackageHIBCC1In Commercial Distribution
B4244002010PrimaryHIBCC0

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.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
942667882
Device count
1
Serial number
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
B4249244420Colonic Irrigation KitSP01 Large Bulb 14429244422016-09-24
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

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
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
B4249214420Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24