DEVICE: Coloplast (05708932020190)
Device Identifier (DI) Information
Coloplast
01003
Not in Commercial Distribution
01003
Coloplast A/S
01003
Not in Commercial Distribution
01003
Coloplast A/S
Coloplast Irrigation Sleeves
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EXD | Irrigator, ostomy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight. Do not use if package is damaged and consult IFU. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e8dd78fc-e93c-4a20-b753-7ce8e7c17c55
October 17, 2024
4
September 14, 2016
October 17, 2024
4
September 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05708932651370 | 20 | 05708932651363 | 2024-06-05 | Not in Commercial Distribution | Shipper Box |
05708932651363 | 10 | 05708932020190 | 2024-06-05 | Not in Commercial Distribution | Retail Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com