Urocare® Male Urinal System, Laced Closue, Large

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Male Urinal System, Laced Closue, Large FDA UDI
Generic Name: Open-ended wearable urine collection bag, non-sterile FDA UDI
Device Name: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, LARGE Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Large #4421, 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. FDA UDI
Model / Reference: 94401 FDA UDI
Description: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, LARGE Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Large #4421, 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. FDA UDI

Identifiers

Catalog Number: 94401 FDA UDI
Primary DI / UDI-DI: 00792293944016 FDA UDI
FDA Product Code: NNX FDA UDI
NNW FDA UDI
KNX FDA UDI
GMDN Term: Open-ended wearable urine collection bag, non-sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 20 Millimeter FDA UDI
Total Volume — 32 Fluid Ounce FDA UDI
Circumference — 40 Millimeter FDA UDI
Total Volume — 1000 Milliliter FDA UDI
Height — 4.00 Inch FDA UDI
Width — 6.25 Inch FDA UDI
Length — 9.00 Inch FDA UDI
Weight — 1.04 Pound FDA UDI

Category: Open-ended wearable urine collection bag, non-sterile Penis/scrotum wearable urinal

Urocare® Male Urinal System, Laced Closue, Large by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Penis/scrotum wearable urinal.

Urocare® Male Urinal Suspensory Garment, Velcro® Closure, Uni 26" to 46" Waist — UROCARE PRODUCTS, INC. · Class I
Urocare® Standard Bottom Drain Valve — UROCARE PRODUCTS, INC. · Class I
Urocare® Male Urinal Sheath, Small 4" — UROCARE PRODUCTS, INC. · Class I
Urocare® Male Urinal System, Velcro® Closue, Large — UROCARE PRODUCTS, INC. · Class I
Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.) — UROCARE PRODUCTS, INC. · Class I
Urocare® Quick Drain Valve™, Standard 10" (25cm) Tube — UROCARE PRODUCTS, INC. · Class I
Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm) — UROCARE PRODUCTS, INC. · Class I
Urocare® Male Urinal Sheath, Large 7" — UROCARE PRODUCTS, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI f2b8fc3f-ab5f-4f71-9286-5dfe617373fd 35 fields · synced May 30, 2026