Duns Number:002348191
Device Description: Pressure Injectable Arrow Chlorag+ard(TM) Midline Kit
Catalog Number
ASK-41541-VAD
Brand Name
ARROW
Version/Model Number
IPN038643
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
K161313,K161313
Product Code
PND
Product Code Name
Midline catheter
Public Device Record Key
f21c8b84-ace5-484b-8e79-5e7a92b22fd1
Public Version Date
November 13, 2020
Public Version Number
5
DI Record Publish Date
September 10, 2018
Package DI Number
20801902143123
Quantity per Package
5
Contains DI Package
10801902143126
Package Discontinue Date
September 21, 2020
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 |