Duns Number:316153865
Device Description: The CLS is a device to monitor blood or saline level in a reservoir and to generate an ele The CLS is a device to monitor blood or saline level in a reservoir and to generate an electrical signal if the level falls below a predetermined value.
Catalog Number
70104.9252
Brand Name
CARDIOHELP System
Version/Model Number
CLS L2.0
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
K102726
Product Code
DTQ
Product Code Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Public Device Record Key
8b0ad736-4c13-4095-92db-6c942e57180c
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 26, 2018
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |