Duns Number:938289980
Device Description: A sterile, porous device used in the arterial line of an extracorporeal circuit, during a A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
Catalog Number
201008-000
Brand Name
Arterial Filter Purge Line
Version/Model Number
201008-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
DTM
Product Code Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Public Device Record Key
754ef161-7a3d-48db-a79e-74c688a145d8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2015
Package DI Number
B0662010080007
Quantity per Package
30
Contains DI Package
B0662010080000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PARTIAL CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |