AccessGUDID - DEVICE: Assura (05708932020206)

GUDID

Device Identifier (DI) Information

Brand Name: Assura
Version or Model: 12820
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12820
Company Name: Coloplast A/S

Primary DI Number: 05708932020206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Assura Irrigation, Face plate

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
Colostomy irrigation ring/belt	A non-sterile device intended to secure a colostomy irrigation sleeve to a colostomy site during evacuation of faeces through the stoma. It is a plastic plate/ring with a flange intended to be secured around the stoma and held in place with an included belt. It is intended for use in the home or healthcare facility. This is a single-patient, reusable device.

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: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e12bdaad-7b9a-4d30-b3a0-ee1731a8fa48
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 14, 2016