FDA.reportPublic FDA data

"Urocare® Male Urinal Sheath, Small 4"""

Primary DI
00792293044099
Brand
"Urocare® Male Urinal Sheath, Small 4"""
Company
UROCARE PRODUCTS, INC.
Model
4409
Catalog number
4409
Device description
"URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, SMALL 4"" (10CM), 4 OZ (118 ML)Replacement sheath for Urocare Male Urinal systems and kits #94399, #94402 & #4399. Includes: 1 Standard Bottom Drain Valve #6004 and Illustrated Use and Care Instructions."
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293044099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293044099007922930440997922930440990792293044099

GMDN Terms#

Term, Definition table
TermDefinition
Penis/scrotum wearable urinalA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length4Inch
Outer Diameter3.38Inch
Total Volume4Fluid Ounce
Total Volume118Milliliter
Weight0.06Pound

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293041005Urocare® Reusable Urinary Drainage Bottle 2,000 mL.410041002018-04-11
00792293041012Urocare® Cap with Housing for Reusable Urinary Drainage Bottle410141012018-04-11
00792293041029Urocare® Hooks for Reusable Urinary Drainage Bottle410241022018-04-11
00792293060013Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve)600160012018-04-11
00792293060037Urocare® Top Adapter for Urinary Drainage Bottle600360032018-04-11
00792293060167Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
00792293060174Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31
00792293060181Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18"601860182018-05-31
00792293060198Urocare® Tubing Clear-Vinyl with Connector 0.31" x 18"601960192018-05-31
00792293060617Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606160612018-04-11
00792293060860Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18"608660862018-05-31
00792293069993Urocare® Thumb Tube Clamp, Adjustable699969992018-04-11
00792293070005Urocare® Thumb Tube Clamp, Two-Position700070002018-04-11
00792293070036Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm)700370032018-06-01
00792293702043Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.)7002047002042018-06-01
00792293702166Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)7002167002162018-06-01
00792293041401Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)414041402018-04-11
00792293060006Urocare® Gasket Ring, Large (Set of 10)600060002018-04-11
00792293060204Urocare® Tubing Clear-Vinyl with Connector and Sterile 0.31" x 18"602060202018-05-31
00792293060600Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606060602018-04-11

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