FDA.reportPublic FDA data

Centurion

Primary DI
00653160177169
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
RI1000
Published
2016-09-14
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
LJHSystem, irrigation, urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJHSystem, Irrigation, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960787000TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSBaxter Healthcare Corp1996-05-14LJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653160177166PackageGS125In Commercial Distribution
00653160177169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316017716610653160177166
00653160177169006531601771696531601771690653160177169

GMDN Terms#

Term, Definition table
TermDefinition
Manual rectal irrigation systemA portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal nozzle/catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.LJH2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.LJH2026-05-05
10704411021544AMSure® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2026-04-10
00191506023348Asurys™BOSTON SCIENTIFIC CORPORATIONLJH2026-04-03
00191506047962Asurys™BOSTON SCIENTIFIC CORPORATIONLJH2026-04-03
10704411016090AMSure ® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
10704411016106AMSure ® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
40704411016091AMSure ® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
40704411016107AMSure ® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
10080196993819MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
10080196993826MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
10080196993833MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
40080196993810MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
40080196993834MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
00628725001012MED-RXCanadian Hospital Specialties LimitedLJH2016-10-19
00628725001043MED-RXCanadian Hospital Specialties LimitedLJH2016-10-18
00628725001050MED-RXCanadian Hospital Specialties LimitedLJH2016-10-18
10884389942604MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10884389942611MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10884389942628MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
00817183020363Flo-Assist IINORTHGATE TECHNOLOGIES INC.LJH2016-10-14
40884389942605MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
40884389942612MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
40884389942629MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10817183020360Flo-Assist IINORTHGATE TECHNOLOGIES INC.LJH2016-10-14
00085412000978NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412000985NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001005NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001029NABAXTER INTERNATIONAL INC.LJH2016-09-24