Duns Number:002348191
Device Description: ARROW ENDURANCE(TM) Extended Dwell Peripheral Catheter System
Catalog Number
EV-00820
Brand Name
ARROW
Version/Model Number
IPN036244
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2016
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
6dc0efa5-8f0d-4ba4-bcaa-a31f76dcd55d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
40801947123054
Quantity per Package
2
Contains DI Package
30801946123058
Package Discontinue Date
October 05, 2016
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 |