MEDLINE INDUSTRIES, INC.

Basic Information

• Brand Name: MEDLINE INDUSTRIES, INC.
• Primary DI: 10080196288663
• Version / Model: NON7916
• Catalog Number: NON7916
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-17
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 39764eff-2bd4-4877-b2b5-32ef13080d26

Device Description

DRESSING,BURN,36"X36",18PLY,STERILE,LF

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
47692	Cotton burn dressing, non-antimicrobial	A covering designed to treat small to large patient burns made of woven cotton impregnated with wound gel (e.g., hydrogel) and applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 1x1 m to 1x2 m), prefabricated shapes (e.g., vest) and may be body contoured; it does not include an antimicrobial agent(s). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40080196288664	GS1	CASE	20	In Commercial Distribution
Primary	10080196288663	GS1

Customer Contacts

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