Duns Number:788403103
Device Description: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only w The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Catalog Number
6300N
Brand Name
FloPump
Version/Model Number
1/4" FloPump (Non-Sterile)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2021
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
K983272
Product Code
KFM
Product Code Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Public Device Record Key
0cf7ec3a-b115-4c61-a62b-1cc96cbe3e15
Public Version Date
December 14, 2021
Public Version Number
5
DI Record Publish Date
November 09, 2015
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |