CLASSIQSwabs™

Basic Information

• Brand Name: CLASSIQSwabs™
• Primary DI: 38053326005597
• Version / Model: 164KS01.US
• Catalog Number: 164KS01.US
• Company Name: COPAN ITALIA SPA
• Labeler DUNS: 428981112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-04-29
• Public Version: 1
• Public Version Date: 2024-05-07
• Public Version Status: New
• Public Device Record Key: 98a06000-fda8-4418-945f-e46d4b18d7dd

Device Description

Sterile Plastic Applicator Poliester Tipped Individually Wrapped

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or 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
Package	58053326005591	GS1		10	In Commercial Distribution
Primary	38053326005597	GS1
Unit of Use	18053326005593	GS1