Urocare® Male Urinal System, Laced Closue, Medium

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Male Urinal System, Laced Closue, Medium FDA UDI
Generic Name: Penis/scrotum wearable urinal FDA UDI
Device Name: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUM Contains: 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. FDA UDI
Model / Reference: 94400 FDA UDI
Description: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUM Contains: 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. FDA UDI

Identifiers

Catalog Number: 94400 FDA UDI
Primary DI / UDI-DI: 00792293944009 FDA UDI
FDA Product Code: KNX FDA UDI
NNW FDA UDI
NNX FDA UDI
GMDN Term: Penis/scrotum wearable urinal FDA UDI

Classification

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

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

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

Similar devices

Also classified as Penis/scrotum wearable urinal.

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Urocare® Male Urinal Sheath, Small 4" — UROCARE PRODUCTS, INC. · Class I
Urocare® Male Urinal System, Velcro® Closue, Large — UROCARE PRODUCTS, INC. · Class I
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Urocare® Male Urinal System, Laced Closue, Large — 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 II	Pending data

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Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI 1624f364-018e-420b-8394-39384921b12f 35 fields · synced Jun 8, 2026