FDA.reportPublic FDA data

Centurion

Primary DI
10653160177166
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
OTC
false
Sterile
false
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 catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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