Duns Number:063997360
Device Description: UNDERPADEXTRA ABSORBENCY24 X 36IN
Catalog Number
3124CV
Brand Name
CARDINAL HEALTH
Version/Model Number
3124CV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 24, 2019
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
KME
Product Code Name
BEDDING, DISPOSABLE, MEDICAL
Public Device Record Key
9e949675-73c3-4bcf-8123-5e2d9016fa7e
Public Version Date
May 10, 2022
Public Version Number
7
DI Record Publish Date
March 16, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 39 |