Duns Number:240623124
Device Description: This device is intended for use during cardiopulmonary bypass in conjunction with other me This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.
Catalog Number
C-665
Brand Name
3/8'' Y Connector w/L.L.
Version/Model Number
2.6
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K833112,K833112
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
68086bc6-0e37-46d0-8ea9-0c1afbe1f93b
Public Version Date
December 10, 2020
Public Version Number
1
DI Record Publish Date
December 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |