Duns Number:002348191
Device Description: Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARR Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
Catalog Number
AK-42802-P1A
Brand Name
ARROW
Version/Model Number
IPN036526
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
K071538,K071538
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
2ecb6d02-53cd-4ada-8aeb-81dbb3648ab1
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
March 08, 2018
Package DI Number
20801902114789
Quantity per Package
5
Contains DI Package
30801902114786
Package Discontinue Date
June 06, 2018
Package Status
Not 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 |