CareOne

Basic Information

• Brand Name: CareOne
• Primary DI: 00041520863430
• Version / Model: 041520863430
• Company Name: Ahold U.S.A., Inc.
• Labeler DUNS: 170199058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-09-27
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: c6afdaa8-1a5e-4021-8b23-0ae4019b45f2

Device Description

Gauze Pads, all one size, 4 IN x 4 IN (101 mm x 101 mm)

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: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10041520078459	GS1	case	72	In Commercial Distribution
Primary	00041520863430	GS1
Unit of Use	60041520863432	GS1

Customer Contacts

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