AccessGUDID - DEVICE: Assura (00762123021354)

GUDID

Device Identifier (DI) Information

Brand Name: Assura
Version or Model: 12834
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12834
Company Name: Coloplast A/S

Primary DI Number: 00762123021354
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Assura Irrigation Sleeves, 2-piece

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:	Yes
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58889	Colostomy irrigation sleeve	A non-sterile, soft plastic, open-ended cylinder intended for use during colostomy irrigation to funnel the resultant washout fluid into a sanitary collection receptacle (e.g., a toilet). It is typically attached to a plastic flange placed around the colostomy stoma and held in place by a waist belt. This is a single-use device.	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

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
Lumen/Inner Diameter: 40 Millimeter
Device Size Text, specify: Coupling Size Diameter - in 1 9/16

Device Record Status

Public Device Record Key: 84168d2e-69d8-4c2d-b4e2-a5284e963f81
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: 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
00762123021361	20	00762123021354		In Commercial Distribution	Shipper Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 05708932020213 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)533-0464
Email: healthcarecs@coloplast.com

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