FDA.reportPublic FDA data

SenSura Mio

Primary DI
05708932750622
Brand
SenSura Mio
Company
Coloplast A/S
Model
11754
Catalog number
11754
Published
2023-11-13
Public version status
New
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
EXDIrrigator, ostomy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932750622PackageGS110In Commercial Distribution
05708932750615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932750622057089327506225708932750622
05708932750615057089327506155708932750615

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.

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136741MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136765MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136789MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136802MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136826MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136840MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136864MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136888MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136901MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136925MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136949MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136963MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136987MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137007MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137021MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137045MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137083MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137090MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137137MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137144MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137175MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137182MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137212MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137229MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071137243MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30