Duns Number:002348191
Device Description: Two-Lumen Central Venous Catheterization Set with ARROWg+ard Blue PLUS(R) Catheter
Catalog Number
CV-46702-E
Brand Name
ARROW
Version/Model Number
IPN030240
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
K993691,K993691
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
b66e323b-e14a-4b38-bf13-1020e69a7a35
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902102523
Quantity per Package
5
Contains DI Package
00801902102522
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 |