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.
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
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
EXE
Product Code Name
Protector, Ostomy
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |