Duns Number:177655466
Device Description: The electronic gas blender is an optional module that integrates into the APS1 chassis. It The electronic gas blender is an optional module that integrates into the APS1 chassis. It accepts inputs of medical grade oxygen and air, or oxygen and 95/5 (a blend of 95% oxygen and 5% carbon dioxide), and allows the ser to control and regulate the gas output to an oxygenator. A built-in oxygen analyzer measures the oxygen content of the blended gas and provides the information to the system for display on the CCM.
Catalog Number
801188
Brand Name
Terumo® Advanced Perfusion System 1
Version/Model Number
801188
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
K151349
Product Code
DTQ
Product Code Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Public Device Record Key
e7ea585b-a06e-4f8b-9420-6dded2d2ea17
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 174 |