Dover

Basic Information

• Brand Name: Dover
• Primary DI: 50192253029978
• Version / Model: 5558492038
• Catalog Number: 5558492038
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2024-07-10
• Public Version: 2
• Public Version Date: 2024-09-09
• Public Version Status: Update
• Public Device Record Key: 5c48dc53-a821-4f0a-9726-8eb3e4a994fc
• Distribution End Date: 2024-08-31

Device Description

Dover Urethral PVC Catheter

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOD	CATHETER, UROLOGICAL	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46626	Intermittent urethral drainage catheter, antimicrobial	A flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal; it is also coated with an antibiotic or antimicrobial agent to help prevent infection of the urinary tract. This is a reusable device on the same patient for a limited period of time.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10192253029970	GS1
Primary	50192253029978	GS1

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French