U.S. Cotton

Basic Information

• Brand Name: U.S. Cotton
• Primary DI: 00048341050070
• Version / Model: S SWPEN2 0205 R04801 USC
• Catalog Number: S SWPEN 0205 R04801 USC
• Company Name: U.S. COTTON, LLC
• Labeler DUNS: 932938897
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 205
• Record Status: Published
• Publish Date: 2021-02-13
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e3a31596-c2be-4018-8a16-4ad18a0f8141
• Distribution End Date: 2022-06-09

Device Description

Single Tip Polyester Swab, Plastic stick

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: 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
KXF	Applicator, Absorbent Tipped, Non-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	10048341050077	GS1	Case	48	Not in Commercial Distribution	2022-06-09
Primary	00048341050070	GS1
Unit of Use	10048341050107	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store indoors under normal ambient conditions in closed package