DEVICE: Coloplast (05708932619813)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
60356 | Colonic lavage nozzle, reusable |
A hollow device intended to be inserted into the rectum and/or colostomy for the administration of irrigation fluid from a connected colonic lavage system or an enema kit. It is typically consists of a one-piece, hollow moulded shape designed to be connected to the enema/lavage system tubing at its proximal end, and be inserted into the rectum or attach to a colostomy at its distal end. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a reusable device after appropriate cleaning.
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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 |
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Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
36e2af52-4040-4e6f-b1e5-c030ac7d5c05
February 20, 2023
4
September 14, 2016
February 20, 2023
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 |
---|---|---|---|---|---|
05708932645829 | 10 | 05708932645812 | In Commercial Distribution | Shipper box | |
05708932645812 | 4 | 05708932619813 | In Commercial Distribution | Retail box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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