Urinary Drainage Catheter

Basic Information

• Brand Name: Urinary Drainage Catheter
• Primary DI: 00350770003191
• Version / Model: UC5.0
• Catalog Number: UC5.0
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-04
• Public Version: 2
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 724dfb5c-9e96-448c-b7ee-251d3659a9b1

Device Description

Urinary Drainage Catheter 5.0Fr

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
EZD	CATHETER, STRAIGHT	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65201	Neonatal indwelling urethral drainage catheter	A flexible tube intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of a neonatal or paediatric patient to function as an indwelling therapeutic device for urinary drainage and which may also be used to sample urine. It may have a bent tip (coude) and some types may be provided with a guidewire to facilitate insertion; it does not include an antimicrobial agent(s) or a balloon. It is intended to be introduced by a healthcare professional. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770003198	GS1	CS	10	In Commercial Distribution
Primary	00350770003191	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072997	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter (Fr)
Length	5	Centimeter