AccessGUDID - DEVICE: Urocare® Male Urinal Sheath, Large 7" (00792293044105)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Male Urinal Sheath, Large 7"
Version or Model: 4410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4410
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293044105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, LARGE 7" (18CM), 9 OZ (270 ML) Replacement sheath for Urocare Male Urinal systems and kits #94404, #94403 & #4401 & 4400. Includes: 1 Standard 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:	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

FDA Product Code

[?]

Product Code	Product Code Name
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
Weight: 0.08 Pound
Total Volume: 270 Milliliter
Total Volume: 9 Fluid Ounce
Length: 7 Inch
Device Size Text, specify: 20mm to 40mm I.D. (Inner Sheath)
Outer Diameter: 3.38 Inch

Device Record Status

Public Device Record Key: cef92de8-5ae7-4d16-b025-85028fcfece3
Public Version Date: June 01, 2018
Public Version Number: 2
DI Record Publish Date: April 12, 2018