AccessGUDID - DEVICE: Coloplast (05708932619813)

GUDID

Device Identifier (DI) Information

Brand Name: Coloplast
Version or Model: 01110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01110
Company Name: Coloplast A/S

Primary DI Number: 05708932619813
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Coloplast Irrigation, Cone

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

GMDN Preferred Term Name	GMDN Definition
Colonic lavage 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.

GMDN Preferred Term Name

GMDN Definition

Colonic lavage 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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36e2af52-4040-4e6f-b1e5-c030ac7d5c05
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2016