DEVICE: Coloplast (05708932619813)

Download: XML | JSON

Device Identifier (DI) Information

Coloplast
01110
01110
Coloplast A/S
05708932619813
GS1
1
Coloplast Irrigation, Cone
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Colonic irrigation nozzle, non-sterile, reusable A non-sterile, 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EXD Irrigator, ostomy
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 14, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
CLOSE