Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) - BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, LARGE, 32 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 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.

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More Product Details

Catalog Number

78321

Brand Name

Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)

Version/Model Number

78321

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KNX

Product Code Name

Collector, Urine, (And Accessories) For Indwelling Catheter

Device Record Status

Public Device Record Key

da6263d5-d474-4a26-a866-2cf5714e0aaf

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

July 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UROCARE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 140
2 A medical device with a moderate to high risk that requires special controls. 6