Duns Number:079455574
Device Description: Console Intake Filter, 5pk
Catalog Number
001-3300-039
Brand Name
OXY-1 System
Version/Model Number
Console Intake Filter, 5pk
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
K200109,K200109
Product Code
DWA
Product Code Name
Control, Pump Speed, Cardiopulmonary Bypass
Public Device Record Key
1f11066a-8e43-450f-a753-4d7aa1b042b8
Public Version Date
December 10, 2020
Public Version Number
1
DI Record Publish Date
December 02, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |