FDA.reportPublic FDA data

Urocare® Male Urinal System, Laced Closue, Medium

Primary DI
00792293944009
Brand
Urocare® Male Urinal System, Laced Closue, Medium
Company
UROCARE PRODUCTS, INC.
Model
94400
Catalog number
94400
Device description
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUMContains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Small #4420, 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.
Published
2018-04-11
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
KNXCollector, Urine, (And Accessories) For Indwelling Catheter
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293944009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293944009007922939440097922939440090792293944009

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
Circumference40Millimeter
Height4Inch
Length9Inch
Lumen/Inner Diameter20Millimeter
Total Volume32Fluid Ounce
Total Volume1000Milliliter
Weight1.04Pound
Width6.25Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
Kit
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957391Create BiotechCREATE BIOTECH CO., LTD.NNW2026-07-21
10192253071108DoverCardinal Health 200, LLCKNX2026-06-24
10192253071139DoverCardinal Health 200, LLCKNX2026-06-24
10192253071146DoverCardinal Health 200, LLCKNX2026-06-24
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
10192253068726DoverCardinal Health 200, LLCKNX2026-01-16
10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10192253068214DoverCardinal Health 200, LLCKNX2026-01-15
10840330701799ProCureTwin Med, LLCKNX2025-05-31
10840330701805ProCureTwin Med, LLCKNX2025-05-31
10192253027792DoverCardinal Health 200, LLCKNX2025-04-01
10192253028232DoverCardinal Health 200, LLCKNX2025-04-01
10192253032161DoverCardinal Health 200, LLCKNX2025-04-01
10192253027945DoverCardinal Health 200, LLCKNX2025-03-20
10192253028461DoverCardinal Health 200, LLCKNX2024-12-20
10192253028522DoverCardinal Health 200, LLCKNX2024-12-20
10192253028539DoverCardinal Health 200, LLCKNX2024-12-20
10192253028546DoverCardinal Health 200, LLCKNX2024-12-20
10192253028560DoverCardinal Health 200, LLCKNX2024-12-20
10192253031126DoverCardinal Health 200, LLCKNX2024-12-20
10192253027938DoverCardinal Health 200, LLCKNX2024-11-04
10192253028287DoverCardinal Health 200, LLCKNX2024-11-04
10192253028492DoverCardinal Health 200, LLCKNX2024-11-04
10192253031447DoverCardinal Health 200, LLCKNX2024-11-04
10192253028195DoverCardinal Health 200, LLCKNX2024-10-14
10192253028201DoverCardinal Health 200, LLCKNX2024-10-14
10192253028263DoverCardinal Health 200, LLCKNX2024-10-14