Duns Number:006261481
Device Description: CANNULA 80324 ART METAL TIP 24FR 20PK 17
Catalog Number
-
Brand Name
DLP®
Version/Model Number
80324
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 25, 2017
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
K840002,K840002
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
8d59dbcf-3953-4f60-9e7b-9ba49e1476a3
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
20613994742425
Quantity per Package
20
Contains DI Package
00613994742421
Package Discontinue Date
August 25, 2017
Package Status
Not in Commercial Distribution
Package Type
PK
| 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 |