Duns Number:002348191
Device Description: ARROW(R) JACC with Chlorag+ard(R) Technology Jugular Axillo-subclavian Central Catheter
Catalog Number
CDC-43052-JX1A
Brand Name
ARROW
Version/Model Number
IPN036741
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K132133,K132133
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
9d259f0c-a421-4415-90dd-6d6d74d9ce4c
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
June 09, 2017
Package DI Number
30801902123931
Quantity per Package
3
Contains DI Package
20801902123934
Package Discontinue Date
January 30, 2019
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 |