Abena

Basic Information

• Brand Name: Abena
• Primary DI: 05713571000441
• Version / Model: 1000021301
• Company Name: Abena North America, Inc
• Labeler DUNS: 078740398
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-08
• Public Version: 4
• Public Version Date: 2023-03-09
• Public Version Status: Update
• Public Device Record Key: c445b238-45dd-4439-b231-b5b173cf4924
• Distribution End Date: 2026-01-01

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	876.5920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05713571000458	GS1	Case	16	Not in Commercial Distribution	2023-01-01
Primary	05713571000441	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store dry, room temperature and no direct sunlight