Urocare® Reusable Urinary Drainage Bottle 2,000 mL.

Basic Information

• Brand Name: Urocare® Reusable Urinary Drainage Bottle 2,000 mL.
• Primary DI: 00792293041005
• Version / Model: 4100
• Catalog Number: 4100
• 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: a0cf87a2-8792-4c25-87f5-45df3b7a3638

Device Description

BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOKS, 64 FL. OZ. (2,000 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, Hooks for Hanging #4102, 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
Package	10792293041002	GS1	Case	12	In Commercial Distribution
Primary	00792293041005	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	64	Fluid Ounce
Width	6.88	Inch
Total Volume	2000	Milliliter
Height	9.75	Inch
Weight	1.46	Pound
Depth	6.88	Inch
Outer Diameter	6.68	Inch