Caroli

Basic Information

• Brand Name: Caroli
• Primary DI: 04000576955809
• Version / Model: 9558376
• Company Name: Abena North America, Inc
• Labeler DUNS: 078740398
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-02
• Public Version: 6
• Public Version Date: 2023-03-09
• Public Version Status: Update
• Public Device Record Key: 5fa58c29-af96-47a8-98cc-659ab906afdf
• Distribution End Date: 2026-01-01

Device Description

Caroli incontinence guards, men

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
35817	Incontinence pants liner	A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04000576883768	GS1	Case	50	Not in Commercial Distribution	2022-01-01
Primary	04000576955809	GS1