Duns Number:002348191
Device Description: Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter For Femoral Vei Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter For Femoral Vein Insertion
Catalog Number
AK-16402
Brand Name
ARROW
Version/Model Number
IPN037177
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K862056,K862056,K862056
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
e229d109-f37e-43ff-b406-d9faf4c7e5e0
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
March 04, 2019
Package DI Number
20801902122180
Quantity per Package
5
Contains DI Package
30801902122187
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |