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Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)

FDA UDI

Class II (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Device Name
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else? Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defects through each phase of manufacturing and packaged individually in an easy-open Zip-Loc® bag with two(2) “latex-free” leg straps and application instructions. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Vinyl on Both Sides, "Latex-Free" Leg Straps with Buttons #60062 and Illustrated Application Instructions. FDA UDI
Model / Reference
78180 FDA UDI
Description
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else? Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defects through each phase of manufacturing and packaged individually in an easy-open Zip-Loc® bag with two(2) “latex-free” leg straps and application instructions. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Vinyl on Both Sides, "Latex-Free" Leg Straps with Buttons #60062 and Illustrated Application Instructions. FDA UDI

Identifiers

Catalog Number
78180 FDA UDI
Primary DI / UDI-DI
00792293781802 FDA UDI
FDA Product Code
KNX FDA UDI
NNW FDA UDI
GMDN Term
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

No

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
Total Volume — 550 Milliliter FDA UDI
Depth — 0.50 Inch FDA UDI
Weight — 0.12 Pound FDA UDI
Total Volume — 18 Fluid Ounce FDA UDI
Height — 13.00 Inch FDA UDI
Width — 4.75 Inch FDA UDI

Category: Wearable adult urine collection bag, open-ended

Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) by Urocare Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as 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 2d00dc5c-d46a-40c1-bf86-74a444f10a23 36 fields · synced May 31, 2026