CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380126376
• Version / Model: LB600T
• Catalog Number: LB600T
• 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: ead56318-be7b-4a64-9b25-0a178274a298

Device Description

Standard Leg Bag 600ml; Pre-connected 18 in. Entension Tube; Twist Valve; Fabric Leg Straps; 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	50885380126374	GS1	CASE	24	In Commercial Distribution
Primary	10885380126376	GS1

Device Sizes

Type	Value	Unit	Text
Height	18	Inch