Duns Number:961027315
Device Description: CENTRAL LINE I PACK
Catalog Number
SCV73CLCEC
Brand Name
CARDINAL HEALTH
Version/Model Number
SCV73CLCEC
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
35b1d2d5-4616-4b2b-88e2-e04fd84a24d6
Public Version Date
November 20, 2019
Public Version Number
1
DI Record Publish Date
November 12, 2019
Package DI Number
50888439543542
Quantity per Package
4
Contains DI Package
10888439543544
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 |