Duns Number:961027315
Device Description: 3 LAYER COMPRESSION BNDG SYSTEM
Catalog Number
CAHMLCB3
Brand Name
CARDINAL HEALTH
Version/Model Number
CAHMLCB3
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"
-
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
b5ed377a-107f-40ae-9390-7d014894bdd3
Public Version Date
December 08, 2021
Public Version Number
3
DI Record Publish Date
July 11, 2019
Package DI Number
50885380055056
Quantity per Package
8
Contains DI Package
20885380055055
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 |