MEDLINE INDUSTRIES, INC.

Basic Information

• Brand Name: MEDLINE INDUSTRIES, INC.
• Primary DI: 10888277400269
• Version / Model: URO53211
• Catalog Number: URO53211
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-05
• Public Version: 2
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: 0e9acea8-ceaa-4b31-9271-13a663743324

Device Description

BAG,DRAINAGE,UROLOGY,2000ML,ANTIREFLUX,E

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNX	COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61355	Urethral catheterization support kit, urinary drainage	A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include 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	20888277400266	GS1	CASE	50	In Commercial Distribution
Primary	10888277400269	GS1

Customer Contacts

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