CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10195594812751
• Version / Model: SCV11AVJH8
• Catalog Number: SCV11AVJH8
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-09
• Public Version: 1
• Public Version Date: 2022-09-19
• Public Version Status: New
• Public Device Record Key: 5c29f8c7-46bd-46f0-be32-8a956ab12291

Device Description

AV FISTULA PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
OEA	Non-surgical isolation gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61040	Cotton burn dressing, antimicrobial	A covering intended to treat small to large patient burns by being placed over the burn to protect against infection, minimize trauma, skin damage and scarring, and to prevent burn progression. It is made of woven cotton, typically available in various sizes, that is coated with a wound cream which includes both an animal-derived ingredient (e.g., beeswax, animal oil/lard) and an antimicrobial agent (e.g., hepericin). 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	50195594812759	GS1	CASE	2	In Commercial Distribution
Primary	10195594812751	GS1