MEDLINE

Basic Information

• Brand Name: MEDLINE
• Primary DI: 10653160373858
• Version / Model: DYNDA2723
• Catalog Number: DYNDA2723
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-25
• Public Version: 1
• Public Version Date: 2024-05-03
• Public Version Status: New
• Public Device Record Key: 095c6cde-0b27-4568-8e16-2a31ad6a4d92

Device Description

SWABSTICKS ALCOHOL 3PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKB	Pad, alcohol, device disinfectant	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
13913	Antiseptic skin swab	A device that is pre-soaked with an antiseptic and intended to inhibit the growth of microorganisms on the skin; it may also include an anaesthetic to alleviate pain. It is typically designed as a sterile cotton swab (a pledget) on a plastic stick and used in the hospital environment, in the home, or carried for first aid to prevent infection and provide temporary pain and itching relief associated with minor cuts, scrapes, or burns. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00653160373851	GS1	CS	20	In Commercial Distribution
Primary	10653160373858	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K833184	000