Duns Number:961027315
Device Description: UNIVERSAL CENTRAL LINE KIT
Catalog Number
17D8060J
Brand Name
CARDINAL HEALTH
Version/Model Number
17D8060J
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
OFF
Product Code Name
Central venous catheter tray
Public Device Record Key
5fcc2904-b981-472e-aa32-43e52a9e30f3
Public Version Date
December 01, 2021
Public Version Number
1
DI Record Publish Date
November 23, 2021
Package DI Number
50195594000460
Quantity per Package
30
Contains DI Package
10195594000462
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 |