Duns Number:006261481
Device Description: SUCTION 10054 10FR SHAFT FRAZIER TIP 17L
Catalog Number
-
Brand Name
DLP®
Version/Model Number
10054
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2018
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
K791846,K791846
Product Code
DTS
Product Code Name
SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
Public Device Record Key
54f68ae3-09b1-4831-aaba-77e58a06fd49
Public Version Date
March 08, 2019
Public Version Number
4
DI Record Publish Date
May 22, 2016
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 |