Duns Number:177655466
Device Description: Level sensors pads are used to attach the level sensors to a hard shell reservoir. Include Level sensors pads are used to attach the level sensors to a hard shell reservoir. Includes coupling gel.
Catalog Number
195240
Brand Name
Terumo® Advanced Perfusion System 1
Version/Model Number
195240
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
K151349,K151349,K151349
Product Code
DTQ
Product Code Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Public Device Record Key
f226e488-5be2-4c4f-85c9-1e5d0d03bc66
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
20886799001701
Quantity per Package
4
Contains DI Package
10886799001704
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 174 |