FDA.reportPublic FDA data

Coloplast

Primary DI
05708932716482
Brand
Coloplast
Company
Coloplast A/S
Model
13650
Catalog number
13650
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
05708932716482PackageGS110In Commercial Distribution
05708932716475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932716482057089327164825708932716482
05708932716475057089327164755708932716475

GMDN Terms#

Term, Definition table
TermDefinition
Colostomy irrigation bagA non-sterile device intended to be used as part of a colostomy irrigation kit to wash out the colon through a colostomy site through gravity. It is in the form of a dedicated container/bag intended to be filled with water/aqueous solution and connected to appropriate tubing; it may include an integrated thermometer and an attached section of tubing but does not include additional colostomy irrigation devices. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This way up.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
true
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
false
No natural rubber latex
false
Sterilization required before use
false

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
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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