Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve)

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve) FDA UDI
Generic Name: Hand-held urinal, reusable FDA UDI
Device Name: VALVE, ANTI-REFLUX, URINE COLLECTION, SILICONE, HIGH-FLOW, REUSABLE, REPLACEMENT Replacement Anti-Reflux Valve for all Urocare Latex Reusable Urine Collection Leg Bags and Drainage Bottles. FDA UDI
Model / Reference: 6001 FDA UDI
Description: VALVE, ANTI-REFLUX, URINE COLLECTION, SILICONE, HIGH-FLOW, REUSABLE, REPLACEMENT Replacement Anti-Reflux Valve for all Urocare Latex Reusable Urine Collection Leg Bags and Drainage Bottles. FDA UDI

Identifiers

Catalog Number: 6001 FDA UDI
Primary DI / UDI-DI: 00792293060013 FDA UDI
FDA Product Code: NNW FDA UDI
KNX FDA UDI
GMDN Term: Hand-held urinal, reusable 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

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 0.01 Pound FDA UDI
Height — 0.77 Inch FDA UDI
Outer Diameter — 0.65 Inch FDA UDI

Category: Open-ended wearable urine collection bag, non-sterile Hand-held urinal, reusable

Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve) by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 b41a7b7f-3382-4e75-b985-006361778d52 36 fields · synced Jun 1, 2026