Duns Number:006261481
Device Description: CONSOLE 560BCS1 CONTROL W/SAFETY BRD MEE
Catalog Number
-
Brand Name
Bio-Console®
Version/Model Number
R560BCS1
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
-
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
K080824
Product Code
DWA
Product Code Name
Control, pump speed, cardiopulmonary bypass
Public Device Record Key
7a47757a-3acc-4e61-a16a-052d315eb3d5
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 14, 2019
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |