DEVICE: SenSura Mio Convex (05708932853330)
Device Identifier (DI) Information
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
31066 | One-piece intestinal ostomy bag, closed-ended |
A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EXB | COLLECTOR, OSTOMY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Base Plate Max Cut Size - mm 33 |
Device Size Text, specify: Descriptive Bag Size Midi |
Device Size Text, specify: Base Plate Max Cut Size - in 1 5/16 |
Device Size Text, specify: Base Plate Type Convex |
Device Size Text, specify: Base Plate Precut Start Hole Size - in 9/16 |
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 15 |
Device Record Status
34a45549-4d36-4dce-a279-09e9e3229ba7
December 12, 2022
1
December 02, 2022
December 12, 2022
1
December 02, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05708932852364 | 10 | 05708932853330 | In Commercial Distribution | Shipper Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
05708932854306
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com