Duns Number:961027315
Catalog Number
CAAP200DL
Brand Name
CARDINAL HEALTH
Version/Model Number
CAAP200DL
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
-
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
64583de2-6b02-420e-a0be-80ad07381c0a
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
June 09, 2019
Package DI Number
50885380068353
Quantity per Package
10
Contains DI Package
70885380068357
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 |