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Urocare® Disposable Urinary Drainage Bag 64 oz. (2, 000 mL.)

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.) FDA UDI
Generic Name
Non-wearable adult urine collection bag, open-ended FDA UDI
Device Name
BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50" Drainage Tube, Reinforced, Universal, Hanger Strap, Anti-Reflux Chamber, Needleless Sample Port, Clear Front with White Back for easy monitoring for blood or other substances in urine, Graduated Nozzle Adapter with Cap, Graduations in 100 mL. and 25 mL., Breather Patch, Bed Sheet Clip and T-Type Drain Valve. FDA UDI
Model / Reference
4200 FDA UDI
Description
BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50" Drainage Tube, Reinforced, Universal, Hanger Strap, Anti-Reflux Chamber, Needleless Sample Port, Clear Front with White Back for easy monitoring for blood or other substances in urine, Graduated Nozzle Adapter with Cap, Graduations in 100 mL. and 25 mL., Breather Patch, Bed Sheet Clip and T-Type Drain Valve. FDA UDI

Identifiers

Catalog Number
4200 FDA UDI
Primary DI / UDI-DI
00792293042002 FDA UDI
FDA Product Code
KNX FDA UDI
FAQ FDA UDI
GMDN Term
Non-wearable adult urine collection bag, open-ended 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Depth — 1.50 Inch FDA UDI
Weight — 0.25 Pound FDA UDI
Height — 10.00 Inch FDA UDI
Total Volume — 2000 Milliliter FDA UDI
Width — 10.00 Inch FDA UDI
Total Volume — 64 Fluid Ounce FDA UDI

Category: Non-wearable adult urine collection bag, open-ended

Urocare® Disposable Urinary Drainage Bag 64 oz. (2, 000 mL.) by Urocare Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-wearable adult urine collection bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urocare Products, Inc.

Sources (1)

  • FDA UDI 1d12be05-5dfa-4700-aefa-38f751ab8fb2 36 fields · synced May 30, 2026