Duns Number:006261481
Device Description: CANNULA 96017 FEM 17ART 21VEN EA 17L
Catalog Number
-
Brand Name
DLP®
Version/Model Number
96017
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
K875353
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
8eda2412-3499-4a0c-bb6e-bc655deb75eb
Public Version Date
December 19, 2018
Public Version Number
4
DI Record Publish Date
April 29, 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 |