← Back to catalogue

Uro-Kit® Reusable Latex Leg Bag System 32 oz.

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Kit® Reusable Latex Leg Bag System 32 oz. FDA UDI
Generic Name
Open-ended wearable urine collection bag, non-sterile FDA UDI
Device Name
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LARGE-OVAL, 32 FL. OZ. (1,000 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8532, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions. FDA UDI
Model / Reference
98532 FDA UDI
Description
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LARGE-OVAL, 32 FL. OZ. (1,000 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8532, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions. FDA UDI

Identifiers

Catalog Number
98532 FDA UDI
Primary DI / UDI-DI
00792293985323 FDA UDI
FDA Product Code
KNX FDA UDI
NNW FDA UDI
EXJ FDA UDI
FFA FDA UDI
MDZ 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
876.5090 FDA UDI
880.6992 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

Yes

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 — 10.0 Inch FDA UDI
Width — 6.0 Inch FDA UDI
Weight — 1.84 Pound FDA UDI
Height — 6.75 Inch FDA UDI
Total Volume — 1000 Milliliter FDA UDI
Total Volume — 32 Fluid Ounce FDA UDI

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

Uro-Kit® Reusable Latex Leg Bag System 32 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Urocare Products, Inc.

Sources (1)

  • FDA UDI c21731c6-6b99-4b93-a33b-60a0f101e324 36 fields · synced May 30, 2026