Duns Number:961027315
Device Description: Cardiothoracic Multi-Port Connector 10mm to 15mm with 3-5mm Drain Ports
Catalog Number
CT-131
Brand Name
CARDINAL HEALTH
Version/Model Number
CT-131
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 29, 2020
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
Yes
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
GCD
Product Code Name
CONNECTOR, CATHETER
Public Device Record Key
6260fe7b-482a-48fb-a420-a3b95442d3e1
Public Version Date
March 02, 2020
Public Version Number
5
DI Record Publish Date
July 10, 2018
Package DI Number
50885380114876
Quantity per Package
8
Contains DI Package
20885380114875
Package Discontinue Date
February 29, 2020
Package Status
Not 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 |