Duns Number:961027315
Catalog Number
CAUP200792
Brand Name
CARDINAL HEALTH
Version/Model Number
CAUP200792
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
-
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
KNN
Product Code Name
COMPONENTS, WHEELCHAIR
Public Device Record Key
e33e92cf-b9e2-40cc-b314-4f8ea7947627
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
June 09, 2019
Package DI Number
50885380051683
Quantity per Package
20
Contains DI Package
10885380051685
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 |