Dover

Basic Information

• Brand Name: Dover
• Primary DI: 10884521016972
• Version / Model: 8887649245
• Catalog Number: 8887649245
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2019-10-28
• Public Version Status: Update
• Public Device Record Key: 8bffbc74-c3e6-41a1-95d7-28d5995d7b91

Device Description

Silicone Elastomer Coated Latex Foley Catheter,Nylon Spiral Reinforced Catheter Wall, 30-50 mL, 3-Way

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
KOD	CATHETER, UROLOGICAL	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34930	Single-administration urethral drainage/irrigation catheter	A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted 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	30884521016976	GS1	CASE	60	In Commercial Distribution
Primary	10884521016972	GS1
Package	20884521016979	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type - Total Volume, 30-50 ML;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry;AVOID DIRECT SUNLIGHT