Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" - TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, NOZZLE ADAPTER, REUSABLE, STERILEFeatures “ TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, NOZZLE ADAPTER, REUSABLE, STERILEFeatures “Reverse-Grip” technology and graduated barbs to provide a secure hold on most standard sized drainage or extension tubing. May be used to connect Uro-Con® or Uro-Cath® male external catheters, Foley® indwelling catheters and reusable or disposable urinary drainage bags, bottles or other urinary and ostomy appliances. Provides a snug fit on most standard sized drainage ports/outlets while resisting kinks.DEHP-Free, Latex-Free and Sterile (EO).Nozzle adapter and cap are preassembled.

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More Product Details

Catalog Number

6060

Brand Name

Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"

Version/Model Number

6060

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

FAQ

Product Code Name

Bag, Urine Collection, Leg, For External Use, Sterile

Device Record Status

Public Device Record Key

89ee7a0c-7ce8-4d55-be03-617162086e73

Public Version Date

May 10, 2021

Public Version Number

8

DI Record Publish Date

April 11, 2018

Additional Identifiers

Package DI Number

10792293060607

Quantity per Package

50

Contains DI Package

00792293060600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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