Urocare® Fabric Foley® Catheter/Tubing Strap Large 22" - STRAP, FABRIC, FOLEY, CATHETER, LATEX-FREE, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: STRAP, FABRIC, FOLEY, CATHETER, LATEX-FREE, VELCRO FASTENERS, REUSABLEThere is an easier w STRAP, FABRIC, FOLEY, CATHETER, LATEX-FREE, VELCRO FASTENERS, REUSABLEThere is an easier way to keep things in their place... Find out how easy it can be to attach your Foley® catheter or tubing with this elastic fabric strap. It's unique design distributes pressure evenly along the length of the strap offering a vast improvement in comfort while reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and/or burns. The self-gripping fastener can engage anywhere along the length of the strap body making the strap fully adjustable to individual requirements. The durable material is hand or machine washable and the strap is available in multiple sizesContains:1 Fabric Catheter Strap,Use and Care Instructions

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More Product Details

Catalog Number

6312

Brand Name

Urocare® Fabric Foley® Catheter/Tubing Strap Large 22"

Version/Model Number

6312

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

-

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

d87dceb1-a949-43ed-80af-c6a6d58f38c5

Public Version Date

December 04, 2020

Public Version Number

8

DI Record Publish Date

May 30, 2018

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