Duns Number:006261481
Device Description: SHUNT 31250 ARTERIOTOMY 2.50MM 5PK 15LA
Catalog Number
-
Brand Name
CLEARVIEW®
Version/Model Number
31250
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120612,K120612
Product Code
DWF
Product Code Name
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Public Device Record Key
9c6063d8-71c5-493b-a4d0-a8f30393babc
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |