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Urocare® Reusable Latex Leg Bag 44 oz.

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Urocare® Reusable Latex Leg Bag 44 oz. FDA UDI
Generic Name
Open-ended wearable urine collection bag, non-sterile FDA UDI
Device Name
BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, EXTRA-LARGE, 44 FL. OZ. (1,300 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions. FDA UDI
Model / Reference
9544 FDA UDI
Description
BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, EXTRA-LARGE, 44 FL. OZ. (1,300 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions. FDA UDI

Identifiers

Catalog Number
9544 FDA UDI
Primary DI / UDI-DI
00792293095442 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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
Weight — 0.44 Pound FDA UDI
Depth — 1 Inch FDA UDI
Width — 4.75 Inch FDA UDI
Height — 20.625 Inch FDA UDI
Total Volume — 44 Fluid Ounce FDA UDI
Total Volume — 1300 Milliliter FDA UDI

Category: Open-ended wearable urine collection bag, non-sterile

Urocare® Reusable Latex Leg Bag 44 oz. by Urocare Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-ended wearable urine collection bag, non-sterile.

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 b6d4a70f-68e5-4f7c-9fc3-3093ce71d843 36 fields · synced Jun 8, 2026