AccessGUDID - DEVICE: Urocare® Quick Drain Valve™, Standard 10" (25cm) Tube (00792293701107)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Quick Drain Valve™, Standard 10" (25cm) Tube
Version or Model: 700110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700110
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293701107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: ADAPTER, QUICK DRAIN, LEVER OPERATED, URINE COLLECTION, LEG BAG, MALE URINAL, REUSABLE Only a limited amount of finger or hand control is required to operate these valves independently. Finger loops or a crossbar may be attached to te lever for individual requirements. Fits Urocare® Reusable Latex Leg Bags and Urocare® Male Urinal Sheaths only. Made with pliable, white-rubber tubing and plastic—no metal parts to corrode. May be used as a replacement for the Standard Bottom Drain Valve (#6004) included with all reusable latex leg bags and Male Urinal Sheaths. An effective crossbar can be made by cutting 2" (5cm) from the bottom of the drain valve tube and pushing one end through the hole in the lever until it is centered, forming a “T” shaped bar. Features: • Lever operated for quick, controlled drainage • Threads are sealed to prevent urine from touching the skin while draining the bag • All working parts are urine free • No metal parts or sharp corners • Tube may be cut to desired length Includes Gasket-Ring #5999 preassembled.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45376	Penis/scrotum wearable urinal	A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device.	Active	false
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile
NNX	Device, Incontinence, Urosheath Type, Non-Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 6 Millimeter
Length: 25 Centimeter
Weight: 0.06 Pound
Length: 10 Inch
Lumen/Inner Diameter: 0.25 Inch

Device Record Status

Public Device Record Key: c1a31f12-1c93-4936-87fb-6eaf6c582909
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: June 01, 2018