Urocare® Male Urinal Sheath, Large 7"

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Male Urinal Sheath, Large 7" FDA UDI
Generic Name: Penis/scrotum wearable urinal FDA UDI
Device Name: URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, LARGE 7" (18CM), 9 OZ (270 ML) Replacement sheath for Urocare Male Urinal systems and kits #94404, #94403 & #4401 & 4400. Includes: 1 Standard Bottom Drain Valve #6004 and Illustrated Use and Care Instructions. FDA UDI
Model / Reference: 4410 FDA UDI
Description: URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, LARGE 7" (18CM), 9 OZ (270 ML) Replacement sheath for Urocare Male Urinal systems and kits #94404, #94403 & #4401 & 4400. Includes: 1 Standard Bottom Drain Valve #6004 and Illustrated Use and Care Instructions. FDA UDI

Identifiers

Catalog Number: 4410 FDA UDI
Primary DI / UDI-DI: 00792293044105 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: Weight — 0.08 Pound FDA UDI
Total Volume — 270 Milliliter FDA UDI
Total Volume — 9 Fluid Ounce FDA UDI
Length — 7 Inch FDA UDI
Outer Diameter — 3.38 Inch FDA UDI

Category: Penis/scrotum wearable urinal

Urocare® Male Urinal Sheath, Large 7" 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 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 I	Pending data

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

Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI cef92de8-5ae7-4d16-b025-85028fcfece3 35 fields · synced May 29, 2026