Duns Number:038000253
Device Description: 7F X 20CM TRIPLE LUMEN INFUSION CATHETER WITH SOFT TIP
Catalog Number
-
Brand Name
Infusion Catheter
Version/Model Number
TRAY #649
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"
Yes
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
-
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
f65c1b0d-91dd-4674-aa93-623b2b33d707
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
50884908056094
Quantity per Package
10
Contains DI Package
00884908056099
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |