Duns Number:961027315
Device Description: Barrier ProtectantNo-sting 1mL ApplicatorAlcohol FreeProtects skin from: IncontinenceBodil Barrier ProtectantNo-sting 1mL ApplicatorAlcohol FreeProtects skin from: IncontinenceBodily FluidsAdhesive Stripping
Catalog Number
CSC-BNS-AP
Brand Name
CARDINAL HEALTH
Version/Model Number
CSC-BNS-AP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
eb73f32b-97bc-4a59-943f-788111059bee
Public Version Date
December 31, 2021
Public Version Number
4
DI Record Publish Date
May 22, 2019
Package DI Number
20885380049108
Quantity per Package
25
Contains DI Package
00885380049104
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| 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 |