Urocare® Standard Bottom Drain Valve

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Standard Bottom Drain Valve FDA UDI
Generic Name: Penis/scrotum wearable urinal FDA UDI
Device Name: VALVE, BOTTOM, DRAIN, URINE COLLECTION, STANDARD, REUSABLE, REPLACEMENT Replacement Bottom Drain Valve for all Urocare Latex Urine Collection Leg Bags and Male Urinal sheaths. Includes Gasket-Ring #5999 preassembled. FDA UDI
Model / Reference: 6004 FDA UDI
Description: VALVE, BOTTOM, DRAIN, URINE COLLECTION, STANDARD, REUSABLE, REPLACEMENT Replacement Bottom Drain Valve for all Urocare Latex Urine Collection Leg Bags and Male Urinal sheaths. Includes Gasket-Ring #5999 preassembled. FDA UDI

Identifiers

Catalog Number: 6004 FDA UDI
Primary DI / UDI-DI: 00792293060044 FDA UDI
FDA Product Code: NNW FDA UDI
KNX 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 0.01 Pound FDA UDI
Height — 1.53 Inch FDA UDI
Outer Diameter — 0.60 Inch FDA UDI

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

Urocare® Standard Bottom Drain Valve 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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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 219f71cc-32c8-459b-97d9-0a5e67495b75 36 fields · synced May 30, 2026