Duns Number:961027315
Device Description: Sting Free Protective Barrier WipeProtects skin for Adhesives, Incontinence, and Bodily Fl Sting Free Protective Barrier WipeProtects skin for Adhesives, Incontinence, and Bodily FluidsNon-irritating to Intact SkinThick, Soft Application PadInstructions: Apply to clean, dry skin. Wipe the desired area of the skin in a smooth sweeping motion until the entire area has a uniform coating. Adhesives can be applied within 30 seconds of application. Re-apply the wipe each time dressing is changed or adhesive products are removed.Warning: For external use only. Single use only. Keep out of reach of children. Caution: DO NOT USE as the only protective covering in situations that require dressing protection from bacterial contamination or on infected areas of the skin. Not made with natural rubber latex. Ingredients: Water, Lipo PEG-55, Tomadol 25-9, DMDM Hydantoin, Glycerin
Catalog Number
ZA20075
Brand Name
CARDINAL HEALTH
Version/Model Number
ZA20075
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
KOX
Product Code Name
SOLVENT, ADHESIVE TAPE
Public Device Record Key
de2d6ddd-c08c-464d-a7e2-31144165537f
Public Version Date
June 13, 2022
Public Version Number
1
DI Record Publish Date
June 03, 2022
Package DI Number
50885380182844
Quantity per Package
16
Contains DI Package
20885380182843
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |