AccessGUDID - DEVICE: Urocare® Male Urinal System, Velcro® Closue, Large (00792293944030)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Male Urinal System, Velcro® Closue, Large
Version or Model: 94403
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 94403
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293944030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGE Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
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
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

FDA Product Code

[?]

Product Code	Product Code Name
NNX	Device, Incontinence, Urosheath Type, Non-Sterile
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter

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: 20 Millimeter
Total Volume: 32 Fluid Ounce
Circumference: 40 Millimeter
Total Volume: 1000 Milliliter
Height: 4.00 Inch
Width: 6.25 Inch
Length: 9.00 Inch
Weight: 1.04 Pound

Device Record Status

Public Device Record Key: 8e9c672e-4d9b-4c05-90a2-678a564e7044
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 11, 2018