Urocare® Reusable Urinary Drainage Bottle 2, 000 mL.

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urocare® Reusable Urinary Drainage Bottle 2,000 mL. FDA UDI
Generic Name: Hand-held urinal, reusable FDA UDI
Device Name: BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOKS, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, DEHP Free, 60" Drainage Tube with Nozzle Adapter and Cap #6061, Urinary Drainage Bottle Adapter #6003, Urinary Drainage Bottle Cap with Housing #4101, Anti-Reflux Valve #6001, , Graduations in 100 mL. increments, Large Opening for Easy Cleaning, Hooks for Hanging #4102, Large Finger Holes for Easy Handling and Adjustable Thumb Tube Clamp #6999. FDA UDI
Model / Reference: 4100 FDA UDI
Description: BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOKS, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, DEHP Free, 60" Drainage Tube with Nozzle Adapter and Cap #6061, Urinary Drainage Bottle Adapter #6003, Urinary Drainage Bottle Cap with Housing #4101, Anti-Reflux Valve #6001, , Graduations in 100 mL. increments, Large Opening for Easy Cleaning, Hooks for Hanging #4102, Large Finger Holes for Easy Handling and Adjustable Thumb Tube Clamp #6999. FDA UDI

Identifiers

Catalog Number: 4100 FDA UDI
Primary DI / UDI-DI: 00792293041005 FDA UDI
FDA Product Code: KNX FDA UDI
GMDN Term: Hand-held urinal, reusable 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 64 Fluid Ounce FDA UDI
Width — 6.88 Inch FDA UDI
Total Volume — 2000 Milliliter FDA UDI
Height — 9.75 Inch FDA UDI
Weight — 1.46 Pound FDA UDI
Depth — 6.88 Inch FDA UDI
Outer Diameter — 6.68 Inch FDA UDI

Category: Hand-held urinal, reusable

Urocare® Reusable Urinary Drainage Bottle 2, 000 mL. 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 a0cf87a2-8792-4c25-87f5-45df3b7a3638 36 fields · synced May 30, 2026