Uro-Kit® Reusable Latex Leg Bag System 9 oz.

Basic Information

• Brand Name: Uro-Kit® Reusable Latex Leg Bag System 9 oz.
• Primary DI: 00792293985095
• Version / Model: 98509
• Catalog Number: 98509
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 09b624b4-e93c-4412-b020-7d35c806299e

Device Description

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SMALL, 9 FL. OZ. (270 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8509, 1 Upper Fabric Leg Strap #6344, 1 Bottle of Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDZ	Cleaners, Medical Devices	General Hospital	880.6992	2
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	876.5090	2
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	876.5250	1
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	876.5250	1
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58924	Open-ended wearable urine collection bag, non-sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293985095	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	9	Fluid Ounce
Total Volume	270	Milliliter
Height	6.75	Inch
Weight	1.70	Pound
Width	6.0	Inch
Depth	10.0	Inch