AccessGUDID - DEVICE: Assura (05708932651448)

GUDID

Device Identifier (DI) Information

Brand Name: Assura
Version or Model: 12830
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12830
Company Name: Coloplast A/S

Primary DI Number: 05708932651448
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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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: Horisontal storage
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00140d77-16e9-4926-9179-9fab19458a98
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016