Duns Number:002348191
Device Description: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit
Catalog Number
ASK-15703-PRWJ1
Brand Name
ARROW
Version/Model Number
IPN034649
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
1e273eb7-6d94-4968-ac2b-b7a0f34d4d5e
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902103827
Quantity per Package
5
Contains DI Package
00801902103826
Package Discontinue Date
March 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 |