U.S. Cotton

Basic Information

• Brand Name: U.S. Cotton
• Primary DI: 00048341011989
• Version / Model: S SWPET(x) 0170 R04801 USC
• Catalog Number: S SWPET 0170 R04801 USC
• Company Name: U.S. COTTON, LLC
• Labeler DUNS: 932938897
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 170
• 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: a65150c3-96f9-4d1c-a1f1-4c265ec809ec
• Distribution End Date: 2022-06-09

Device Description

Single Tip Polyester Swab, Plastic stick (S SWPET / S SWPET1 / S SWPET2 case pack variations)

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
Unit of Use	10048341050091	GS1
Primary	00048341011989	GS1
Package	10048341011986	GS1	Case	48	Not in Commercial Distribution	2022-06-09
Package	60048341011981	GS1	Case	48	Not in Commercial Distribution	2022-06-09
Package	70048341011988	GS1	Case	48	Not in Commercial Distribution	2022-06-09

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