FDA.reportPublic FDA data

Assura

Primary DI
00762123021354
Brand
Assura
Company
Coloplast A/S
Model
12834
Catalog number
12834
Device description
Assura Irrigation Sleeves, 2-piece
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
EXDIrrigator, ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXDIrrigator, OstomyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123021361PackageGS120In Commercial Distribution
00762123021354PrimaryGS10
05708932020213Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123021361007621230213617621230213610762123021361
00762123021354007621230213547621230213540762123021354
05708932020213057089320202135708932020213

GMDN Terms#

Term, Definition table
TermDefinition
Colostomy irrigation sleeveA non-sterile, soft plastic, open-ended cylinder intended for use during colostomy irrigation to funnel the resultant washout fluid into a sanitary collection receptacle (e.g., a toilet). It is typically attached to a plastic flange placed around the colostomy stoma and held in place by a waist belt. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136734MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136741MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136758MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136765MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136772MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136789MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136796MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136802MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136819MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136826MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136833MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136840MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136857MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136864MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136871MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136888MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136895MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136901MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136918MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136925MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136932MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30