Duns Number:961027315
Device Description: BANDAGE COMPRESSION 3IN X 5YD SELF ADHERENT CASE PACK NONSTERILE BLACK
Catalog Number
CAH35LFBK
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH35LFBK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 18, 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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
49e75f71-53fa-4003-8968-230bd1846188
Public Version Date
December 08, 2021
Public Version Number
5
DI Record Publish Date
June 30, 2019
Package DI Number
10888499007161
Quantity per Package
2
Contains DI Package
00888499007164
Package Discontinue Date
November 18, 2021
Package Status
Not 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 |