SenSura Mio Flex

Basic Information

• Brand Name: SenSura Mio Flex
• Primary DI: 05708932131292
• Version / Model: 13645
• Catalog Number: 13645
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 01142c4f-b220-41b2-9ba0-797c9dd30ea8

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXB	COLLECTOR, OSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31076	Multiple-piece intestinal ostomy bag, open-ended	A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device.	No	Active
48159	Intestinal ostomy base plate, flat	A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932131483	GS1	Retail Box	5	In Commercial Distribution
Primary	05708932131292	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Base Plate Precut Start Hole Size - mm 10
Total Volume	655	Milliliter
Device Size Text, specify			Base Plate Max Cut Size - mm 48
Device Size Text, specify			Base Plate Max Cut Size - in 1 7/8
Device Size Text, specify			Base Plate Type Flat
Device Size Text, specify			Base Plate Precut Start Hole Size - in 3/8
Device Size Text, specify			Coupling Size Diameter - in 1 15/16
Lumen/Inner Diameter	50	Millimeter