Uro-Prep® Protective Skin Barrier Wipes (Box of 50) - PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, SACHETTE, URINE COLLECTION, OSTOMY, MALE PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, SACHETTE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE Uro-Prep® Protective Barrier has been specifically formulated to create a protective barrier between delicate, sensitive skin and aggressive adhesives. They can be used under all types of medical adhesives. Packaged in a small, convenient wipe, Uro-Prep® skin barrier wipes are the perfect solution to aid in the protection of delicate skin that has become sensitive to repeated use of medical adhesives; especially, those used to secure male external urinary catheters and urinary or ostomy appliances. Uro-Prep® protective skin barrier wipes are alcohol based which are easy to apply, safe, effective. It is recommended that a male external catheter be changed once a day to promote healthy skin and using Uro-Prep® protective skin barrier wipes before applying a male external catheter, urinary or ostomy appliance will help protect skin from any aggressive adhesives used with their application.Key Features:• Alcohol Based—Dries quickly for fast use.• Many Uses—Can be used under all types of medical adhesives• Convenient—Travel size pads are small and easy to use• Soap & Water Clean-Up—Just wash, rinse and dry• Suitable for Hospital, Long-Term Care and Home Use• Reduces Adhesive Removal Trauma• Environmentally Friendly—Does not contain ozone-depleting chloro-fluorocarbons• Convenient Packaging—Use only what you need so there's less wasteNote: For external use only.

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More Product Details

Catalog Number

5500

Brand Name

Uro-Prep® Protective Skin Barrier Wipes (Box of 50)

Version/Model Number

5500

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"

-

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

EXE

Product Code Name

Protector, Ostomy

Device Record Status

Public Device Record Key

75567a13-2eae-435c-8c08-3ef721bfbe65

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

June 01, 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