Duns Number:533658675
Device Description: 24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, with suction 24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, with suction port in tip to allow emboli removal during cardiopulmonary bypass.
Catalog Number
CGT2422
Brand Name
CardioGard Emboli Protection Cannula
Version/Model Number
CGT2422
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"
-
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
K182302,K182302,K182302
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
e74d214c-7714-4d16-a323-613d89359824
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
June 01, 2022
Package DI Number
17290016069010
Quantity per Package
10
Contains DI Package
07290016069013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box