Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)

Basic Information

• Brand Name: Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)
• Primary DI: 00792293041401
• Version / Model: 4140
• Catalog Number: 4140
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-11
• Public Version: 4
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 10bdec69-09f1-47ae-bccc-0f7ca1b50b39

Device Description

BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, EXTRA-LARGE, REUSABLE, RIGID HDPE, TUBE, 128 FL. OZ. (4,000 ML.) Contains/Features Include: Latex-Free, DEHP Free, 60" Drainage Tube with Nozzle Adapter and Cap #6061, Urinary Drainage Bottle Adapter #6003, Urinary Drainage Bottle Cap with Housing #4101, Anti-Reflux Valve #6001, , Graduations in 100 mL. increments, Large Opening for Easy Cleaning, Large Finger Holes for Easy Handling and Adjustable Thumb Tube Clamp #6999.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40504	Hand-held urinal, reusable	A portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293041401	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	5.50	Inch
Weight	1.32	Pound
Height	13.00	Inch
Total Volume	4000	Milliliter
Width	7.75	Inch
Total Volume	128	Fluid Ounce