Abena

Basic Information

• Brand Name: Abena
• Primary DI: 00190509001612
• Version / Model: 2593
• Company Name: Abena North America, Inc
• Labeler DUNS: 078740398
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-05
• Public Version: 8
• Public Version Date: 2023-03-09
• Public Version Status: Update
• Public Device Record Key: 86adf9ba-4342-45ea-bf30-43f2e9fc32b4
• Distribution End Date: 2026-01-01

Device Description

Abena Essentials washable Underpads that measures 35" x 42".

Device Characteristics

• Single Use: No
• 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: No
• 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
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190509001612	GS1
Package	00190509001674	GS1	Case	30	Not in Commercial Distribution	2022-01-01

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight and water.