Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)

Basic Information

• Brand Name: Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)
• Primary DI: 00792293042002
• Version / Model: 4200
• Catalog Number: 4200
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-10
• Public Version: 5
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 1d12be05-5dfa-4700-aefa-38f751ab8fb2

Device Description

BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50" Drainage Tube, Reinforced, Universal, Hanger Strap, Anti-Reflux Chamber, Needleless Sample Port, Clear Front with White Back for easy monitoring for blood or other substances in urine, Graduated Nozzle Adapter with Cap, Graduations in 100 mL. and 25 mL., Breather Patch, Bed Sheet Clip and T-Type Drain Valve.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10792293042009	GS1	Case	20	In Commercial Distribution
Primary	00792293042002	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	1.50	Inch
Weight	0.25	Pound
Height	10.00	Inch
Total Volume	2000	Milliliter
Width	10.00	Inch
Total Volume	64	Fluid Ounce