CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10195594973636
• Version / Model: 03-4971B
• Catalog Number: 03-4971B
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 1542103f-5f14-4051-a7af-bcac929b40cb

Device Description

FISTULA ON OFF KIT

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
FKG	TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS	Gastroenterology, Urology	876.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60755	Urological surgical procedure kit, non-medicated, single-use	A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50195594973634	GS1	CASE	50	In Commercial Distribution
Primary	10195594973636	GS1