Care One

Basic Information

• Brand Name: Care One
• Primary DI: 00041520874825
• Version / Model: F405-605CO1
• Company Name: APOTHECARY PRODUCTS, LLC
• Labeler DUNS: 092312735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-01-09
• Public Version: 3
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 8be04c61-849e-4953-8f0d-885f53ef8d9e

Device Description

High Filtration Efficiency Face Mask

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
MSH	Respirator, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57793	Public respirator, single-use	A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large and small particles when considered necessary (e.g., viral epidemic). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10041520974829	GS1	Box	4	In Commercial Distribution
Package	20025715036575	GS1	Bag	6	In Commercial Distribution
Primary	00041520874825	GS1
Unit of Use	04004152087489	GS1

Customer Contacts

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