Duns Number:002348191
Device Description: ARROW ENDURANCE(TM) Extended Dwell Peripheral Catheter System
Catalog Number
EV-00820
Brand Name
ARROW
Version/Model Number
IPN035733
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
-
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
5db658fb-49ca-4370-a50d-dcba4f94b15e
Public Version Date
August 07, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
20801902092681
Quantity per Package
10
Contains DI Package
00801902092687
Package Discontinue Date
June 20, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |