Urocare® Gasket Ring, Large (Set of 10)

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Gasket Ring, Large (Set of 10) FDA UDI
Generic Name: Open-ended wearable urine collection bag, non-sterile FDA UDI
Device Name: GASKET RING, VALVE, URINE COLLECTION, LARGE, REUSABLE, REPLACEMENT, SET OF 10 Replacement Gasket-Ring for: Urinary Drainage Bottle 2,000 mL. #4100, Urinary Drainage Bottle 4,000 mL. #4140 and Anti-Reflux Valve #6001 found in all Urocare Latex Urinary Leg Bags. FDA UDI
Model / Reference: 6000 FDA UDI
Description: GASKET RING, VALVE, URINE COLLECTION, LARGE, REUSABLE, REPLACEMENT, SET OF 10 Replacement Gasket-Ring for: Urinary Drainage Bottle 2,000 mL. #4100, Urinary Drainage Bottle 4,000 mL. #4140 and Anti-Reflux Valve #6001 found in all Urocare Latex Urinary Leg Bags. FDA UDI

Identifiers

Catalog Number: 6000 FDA UDI
Primary DI / UDI-DI: 00792293060006 FDA UDI
FDA Product Code: KNX FDA UDI
NNW FDA UDI
GMDN Term: Open-ended wearable urine collection bag, non-sterile FDA UDI

Classification

Device Class: Class II 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Depth — 0.07 Inch FDA UDI
Weight — 0.01 Pound FDA UDI
Outer Diameter — 0.65 Inch FDA UDI

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

Urocare® Gasket Ring, Large (Set of 10) by Urocare Products, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI c1e2e3b0-70c0-4e95-8423-63236751079f 36 fields · synced Jun 8, 2026