Urocare® Male Urinal Kit, Laced Closue, Medium

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Male Urinal Kit, 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 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: 4400 FDA UDI
Description: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUM Contains: 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: 4400 FDA UDI
Primary DI / UDI-DI: 00792293044006 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: Not 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

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Depth — 1.63 Inch FDA UDI
Lumen/Inner Diameter — 20 Millimeter FDA UDI
Total Volume — 9 Fluid Ounce FDA UDI
Circumference — 40 Millimeter FDA UDI
Total Volume — 270 Milliliter FDA UDI
Height — 9.25 Inch FDA UDI
Width — 5.63 Inch FDA UDI
Weight — 0.45 Pound FDA UDI

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

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 c3f10f59-30c7-4b20-aab9-70dc16ba477c 36 fields · synced May 31, 2026