Duns Number:961027315
Device Description: BANDAGE COMPRESSION 1IN X 5YD SELF ADHERENT MULTI PACK NONSTERILE
Catalog Number
CAH15LFMP
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH15LFMP
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
dee1d526-6aac-425d-83b7-97fbd57c43d4
Public Version Date
July 12, 2019
Public Version Number
8
DI Record Publish Date
July 07, 2018
Package DI Number
20885380126007
Quantity per Package
12
Contains DI Package
10885380126000
Package Discontinue Date
-
Package Status
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 |