Duns Number:442126587
Catalog Number
-
Brand Name
Intracardiac Sucker
Version/Model Number
S352-80
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
K900339,K900339
Product Code
DTS
Product Code Name
SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
Public Device Record Key
ff7522bb-7d6b-4b86-b1dc-893e7c270dbd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 21, 2016
Package DI Number
38033178004498
Quantity per Package
10
Contains DI Package
08033178004497
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 398 |
| 3 | A medical device with high risk that requires premarket approval | 78 |