AccessGUDID - DEVICE: Abena (05713571000441)

GUDID

Device Identifier (DI) Information

Brand Name: Abena
Version or Model: 1000021301
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Abena North America, Inc

Primary DI Number: 05713571000441
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 078740398 *Terms of Use

Device Description: Abena San Premium holds 7 fluid ounces/200 ml, for individuals for width and length measurements of 9x4". It has an adhesive strip to place on underwear and avoid it from moving around.

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):	No
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?
11239	Adult nappy	A disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYQ	Garment, Protective, For Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Store dry, room temperature and no direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c445b238-45dd-4439-b231-b5b173cf4924
Public Version Date: March 09, 2023
Public Version Number: 4
DI Record Publish Date: August 08, 2022