Urocare® Male Urinal Sheath, Small 4"

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Male Urinal Sheath, Small 4" FDA UDI
Generic Name: Penis/scrotum wearable urinal FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 4409 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 4409 FDA UDI
Primary DI / UDI-DI: 00792293044099 FDA UDI
FDA Product Code: NNX FDA UDI
GMDN Term: Penis/scrotum wearable urinal 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

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: Length — 4 Inch FDA UDI
Total Volume — 4 Fluid Ounce FDA UDI
Total Volume — 118 Milliliter FDA UDI
Weight — 0.06 Pound FDA UDI
Outer Diameter — 3.38 Inch FDA UDI

Category: Penis/scrotum wearable urinal

Urocare® Male Urinal Sheath, Small 4" by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Penis/scrotum wearable urinal.

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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
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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

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Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI 8f941725-8b98-48ee-b05a-9d474296e5e6 35 fields · synced Jun 1, 2026