Duns Number:961027315
Device Description: KIT, OR CLEAN UP
Catalog Number
ORC3L6899B
Brand Name
CARDINAL HEALTH
Version/Model Number
ORC3L6899B
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PWU
Product Code Name
Clean-up kit
Public Device Record Key
f4ba292d-c0a8-45a8-8b8a-a64e2eee5af7
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 18, 2022
Package DI Number
50195594539175
Quantity per Package
15
Contains DI Package
10195594539177
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 |