Duns Number:961027315
Device Description: Self Adherent Cohesive Compression Bandage 2inx5yd NonSterile
Catalog Number
CAH25LFMP
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH25LFMP
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
1c3a5bde-b0ac-46bf-acbb-f35258425559
Public Version Date
July 07, 2020
Public Version Number
8
DI Record Publish Date
July 07, 2018
Package DI Number
20885380126014
Quantity per Package
12
Contains DI Package
10885380126017
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 |