Duns Number:316153865
Device Description: BO-RF-32-USA#RotaFlow Centrifugal Pump with SOFTLINE Coating
Catalog Number
70104.7553
Brand Name
ROTAFLOW
Version/Model Number
Centrifugal Pump, SOFTLINE
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
K090515,K090515
Product Code
KFM
Product Code Name
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Public Device Record Key
5bd5800b-b14d-4d03-bb8a-305256fb23ee
Public Version Date
May 19, 2020
Public Version Number
4
DI Record Publish Date
October 30, 2015
Package DI Number
04037691650333
Quantity per Package
10
Contains DI Package
04037691650326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |