SenSura Mio

Basic Information

• Brand Name: SenSura Mio
• Primary DI: 05708932750615
• Version / Model: 11754
• Catalog Number: 11754
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-13
• Public Version: 1
• Public Version Date: 2023-11-21
• Public Version Status: New
• Public Device Record Key: 8bdf5a38-b14f-4dfd-92e5-a756e88c092c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXD	Irrigator, ostomy	Gastroenterology, Urology	876.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58889	Colostomy irrigation sleeve	A 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.	No	Active
58888	Colostomy irrigation kit, reusable	A collection of non-sterile devices designed to wash out the colon through a colostomy site. It typically includes a container of fluid, tubing with a cone-shaped tip, or a soft and flexible catheter with a retention shield; it may include some disposables. This is a reusable device after appropriate cleaning.	No	Active
60968	Ostomy appliance ring/belt	A device consisting of a ring/plate and an adjustable and/or elastic belt intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the ring, which is attached to the belt worn by the patient. The device is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a single-patient, reusable device.	No	Active
61021	Colostomy irrigation bag	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932750622	GS1	Shipper Box	10	In Commercial Distribution
Primary	05708932750615	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]