CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380126338
• Version / Model: LB600R
• Catalog Number: LB600R
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 4fa9e1d3-9c6d-44c9-ace9-c2bb6ae4c68d

Device Description

Standard Leg Bag 600ml; Twist Valve; Fabric Leg Strap; Sterile Fluid Pathways

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: 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
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58919	Wearable adult urine collection bag, closed-ended	A flexible plastic pouch designed to connect to a urinary catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is not designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility and is disposed of when full. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380126336	GS1	CASE	48	In Commercial Distribution
Primary	10885380126338	GS1