FDA.reportPublic FDA data

Urocare® Male Urinal System, Velcro® Closue, Small

Primary DI
00792293944023
Brand
Urocare® Male Urinal System, Velcro® Closue, Small
Company
UROCARE PRODUCTS, INC.
Model
94402
Catalog number
94402
Device description
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, SMALL Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Small #4409, 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
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293944023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293944023007922939440237922939440230792293944023

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place away from direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(909) 621-6013cust.support@urocare.com

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm5301245301242025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm5301285301282025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm5301315301312025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm5301355301352025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm5301405301402025-01-01
00792293781802Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78180781802020-07-30
00792293781819Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78181781812020-07-30
00792293783202Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78320783202020-07-30
00792293783219Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78321783212020-07-30
00792293791801Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79180791802020-07-30
00792293791818Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79181791812020-07-30
00792293793201Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79320793202020-07-30
00792293793218Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79321793212020-07-30
10792293042009Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)420042002018-04-10
10792293060096Urocare® Tubing Connector, Small 0.31" OD x 2.25"600960092018-06-01
10792293060102Urocare® Tubing Connector, Large 0.38" OD x 2.25"601060102018-06-01
10792293060133Urocare® Catheter Connector, Small 0.31" OD x 3"601360132018-05-31
10792293060140Urocare® Catheter Connector, Large 0.38" OD x 3"601460142018-05-31
10792293060164Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
10792293060171Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501263FOOT URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
04816415501270BEDSIDE URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
50192253068601DoverCardinal Health 200, LLCKNX2026-01-16
50192253068717DoverCardinal Health 200, LLCKNX2026-01-16
50192253068724DoverCardinal Health 200, LLCKNX2026-01-16
50192253068731DoverCardinal Health 200, LLCKNX2026-01-16
50192253067987DoverCardinal Health 200, LLCKNX2026-01-15
50192253068014DoverCardinal Health 200, LLCKNX2026-01-15
50192253068212DoverCardinal Health 200, LLCKNX2026-01-15
16974500612586Disposable Urinary Drainage BagGCMEDICA ENTERPRISE LTD.(WUXI)KNX2025-08-07
30840330701793ProCureTwin Med, LLCKNX2025-05-31
30840330701809ProCureTwin Med, LLCKNX2025-05-31
50192253027790DoverCardinal Health 200, LLCKNX2025-04-01
50192253028230DoverCardinal Health 200, LLCKNX2025-04-01
50192253032169DoverCardinal Health 200, LLCKNX2025-04-01
50192253030059DoverCardinal Health 200, LLCKNX2025-04-01
50192253027943DoverCardinal Health 200, LLCKNX2025-03-20
50850045818390TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50850045818406TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50192253028568DoverCardinal Health 200, LLCKNX2024-12-20
50192253028520DoverCardinal Health 200, LLCKNX2024-12-20
50192253028537DoverCardinal Health 200, LLCKNX2024-12-20
50192253028544DoverCardinal Health 200, LLCKNX2024-12-20
50192253028469DoverCardinal Health 200, LLCKNX2024-12-20
50192253031124DoverCardinal Health 200, LLCKNX2024-12-20
50192253028551DoverCardinal Health 200, LLCKNX2024-12-20
50192253027936DoverCardinal Health 200, LLCKNX2024-11-04
50192253028285DoverCardinal Health 200, LLCKNX2024-11-04
50192253028490DoverCardinal Health 200, LLCKNX2024-11-04
50192253031445DoverCardinal Health 200, LLCKNX2024-11-04