CareOne

Basic Information

• Brand Name: CareOne
• Primary DI: 00041520863904
• Version / Model: B FMDLS 0130 R03606 AHL
• Company Name: U.S. COTTON, LLC
• Labeler DUNS: 932938897
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 130
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 2
• Public Version Date: 2023-06-06
• Public Version Status: Update
• Public Device Record Key: cf788e0a-2227-4a59-84b8-4ddb545c6272
• Distribution End Date: 2023-06-05

Device Description

Sterile Cotton Balls (130ct Medium Size)

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63281	Cotton wool ball	A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10041520078466	GS1	Case	36	Not in Commercial Distribution	2023-06-05
Primary	00041520863904	GS1
Unit of Use	10048341800016	GS1

Storage Conditions

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