Duns Number:961027315
Device Description: Barrier Protectant No-Sting WipeAlcohol FreeProtects skin from: IncontinenceBodily fluidsA Barrier Protectant No-Sting WipeAlcohol FreeProtects skin from: IncontinenceBodily fluidsAdhesive stripping
Catalog Number
CSC-BNS-WP
Brand Name
CARDINAL HEALTH
Version/Model Number
CSC-BNS-WP
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"
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
NEC
Product Code Name
Bandage, liquid, skin protectant
Public Device Record Key
d0292d3a-1688-43a8-855a-f4b0ba20cf92
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
May 22, 2019
Package DI Number
50885380049116
Quantity per Package
10
Contains DI Package
20885380049115
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 |