DEVICE: Assura (05708932651448)
Device Identifier (DI) Information
Assura
12830
In Commercial Distribution
12830
Coloplast A/S
12830
In Commercial Distribution
12830
Coloplast A/S
Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
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.
|
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: Horisontal storage |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
00140d77-16e9-4926-9179-9fab19458a98
March 29, 2018
2
September 22, 2016
March 29, 2018
2
September 22, 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 |
---|---|---|---|---|---|
05708932651455 | 12 | 05708932651448 | 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:
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