CareOne

Basic Information

• Brand Name: CareOne
• Primary DI: 00041520104854
• Version / Model: 041520104854
• Company Name: Ahold U.S.A., Inc.
• Labeler DUNS: 170199058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 3
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 31fcdf0d-27f5-47c1-bb55-5f32484b334c

Device Description

Hydrocolloid Blister Cushions, assorted cushions, 0.66 in. x 2.32 in. (17mm x 59mm); 1.33 in. x 2.12in. (34mm x 54mm); 1.65 IN x 2.67 IN (42 mm x 68 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62873	Exudate-absorbent dressing, hydrophilic-gel, non-sterile	A non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) and/or minor abrasions by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.	No	Obsolete
61945	Corn/callus dressing, single-use	An adhesive dressing intended for protection of corns or calluses (hardened areas of skin on the feet or toes) or unopened blisters, and to maintain a moist environment to allow the lesion to heal. It consists of a pad of material (e.g., hydrocolloid) and may be impregnated with an acid (e.g., salicylic) which acts as a keratolytic agent to facilitate the removal of dead skin. It may be supplied with another dressing (e.g., ring) to provide additional protection/cushioning around the lesion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10041520104851	GS1	case	24	In Commercial Distribution
Primary	00041520104854	GS1
Unit of Use	60041520104856	GS1