QuickChange, 10 Count Pack

Basic Information

• Brand Name: QuickChange, 10 Count Pack
• Primary DI: 00861859000463
• Version / Model: V 2.0
• Company Name: Ui Medical, LLC
• Labeler DUNS: 080688136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-26
• Public Version: 1
• Public Version Date: 2023-08-03
• Public Version Status: New
• Public Device Record Key: 2bf35a9a-b48b-4a52-8909-19d147f885c9

Device Description

QuickChange for Male Incontinence, 10 Count Pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Primary	00861859000463	GS1

Customer Contacts

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