ONE-CARE Alcohol Prep Pads

Basic Information

• Brand Name: ONE-CARE Alcohol Prep Pads
• Primary DI: 00810008211700
• Version / Model: ONE-CARE Alcohol Prep Pads, 70%, M, Box of 200
• Catalog Number: 1022
• Company Name: MediVena, LLC
• Labeler DUNS: 080740980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-18
• Public Version: 1
• Public Version Date: 2023-10-26
• Public Version Status: New
• Public Device Record Key: a10d5408-33b1-4f67-8bd4-41867bf2b35f

Device Description

ONE-CARE Alcohol Prep Pads are saturated with 70% Isopropyl Alcohol for optimal antiseptic action. They are intended for topical use in preparation of skin prior to an injection or blood collection, cleaning of minor cuts and scrapes, or cleaning of medical equipment and supplies. Reliable 4-layer packaging provides air-tight seal and prevents leakage or dry-out.

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61695	Skin-cleaning wipe, sterile	A sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810008211694	GS1	case	50	In Commercial Distribution
Primary	00810008211700	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit