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Urocare® Upper Fabric Leg Strap with Velcro® Fasteners, Large 12" ~ 21" DIA.

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Urocare® Upper Fabric Leg Strap with Velcro® Fasteners, Large 12" ~ 21" DIA. FDA UDI
Generic Name
Open-ended wearable urine collection bag, non-sterile FDA UDI
Device Name
STRAP, FABRIC, UPPER, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9544, #9532, #9526, #8532, #8526, #8518 and #8509. Offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the strap loops of the leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. * BAGS MUST HAVE STRAP LOOPS FOR STRAP TIES TO PASS THROUGH FDA UDI
Model / Reference
6344 FDA UDI
Description
STRAP, FABRIC, UPPER, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9544, #9532, #9526, #8532, #8526, #8518 and #8509. Offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the strap loops of the leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. * BAGS MUST HAVE STRAP LOOPS FOR STRAP TIES TO PASS THROUGH FDA UDI

Identifiers

Catalog Number
6344 FDA UDI
Primary DI / UDI-DI
00792293063441 FDA UDI
FDA Product Code
FAQ FDA UDI
NNW FDA UDI
KNX FDA UDI
GMDN Term
Open-ended wearable urine collection bag, non-sterile FDA UDI

Classification

Device Class
Class I 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 0.04 Pound FDA UDI

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

Urocare® Upper Fabric Leg Strap with Velcro® Fasteners, Large 12" ~ 21" DIA. by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID

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 d45bbd21-7936-40a8-9cde-aeb779e58870 36 fields · synced Jun 7, 2026