Urocare® Tubing Connector, Large 0.38" OD x 2.25"

Basic Information

• Brand Name: Urocare® Tubing Connector, Large 0.38" OD x 2.25"
• Primary DI: 00792293060105
• Version / Model: 6010
• Catalog Number: 6010
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 1135c572-fd2d-428f-82b8-39ac689683c0

Device Description

TUBING, URINE COLLECTION, OSTOMY, WHITE-RUBBER, CONNECTOR, CATHETER, REUSABLE Features “Reverse-Grip” technology and graduated barbs to provide a secure hold on most standard sized drainage or extension tubing. May be used to connect Uro-Con® or Uro-Cath® male external catheters, Foley® indwelling catheters and reusable or disposable urinary drainage bags, bottles or other urinary and ostomy appliances. DEHP-Free and Latex-Free.

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
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	876.5250	1
FAQ	Bag, Urine Collection, Leg, For External Use, 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
34929	Urinary incontinence penis sheath/port, single-use	A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.	No	Active
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
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	10792293060102	GS1	Box	10	In Commercial Distribution
Primary	00792293060105	GS1
Package	20792293060109	GS1	Case	50	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.31	Inch
Length	2.25	Inch
Outer Diameter	0.38	Inch
Weight	0.009	Pound
Outer Diameter	9.6	Millimeter
Length	5.7	Centimeter
Lumen/Inner Diameter	8	Millimeter