Duns Number:002348191
Device Description: Arrow(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
Catalog Number
ASK-04001-DU5S1
Brand Name
ARROW
Version/Model Number
IPN036060
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
K100635,K100635
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
2e0a3bc8-5bfa-4b79-bd4e-8c1309400148
Public Version Date
October 06, 2020
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
30801902111549
Quantity per Package
5
Contains DI Package
00801902111548
Package Discontinue Date
April 09, 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 |