Duns Number:002348191
Device Description: Arterial Catheterization Kit
Catalog Number
ASK-04020-SHUF
Brand Name
ARROW
Version/Model Number
IPN056190
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K810675,K810675,K810675
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
ef56d5c7-3391-4f0b-9bb3-64c21c28a86e
Public Version Date
September 17, 2021
Public Version Number
2
DI Record Publish Date
March 26, 2021
Package DI Number
40801902160711
Quantity per Package
5
Contains DI Package
30801902160714
Package Discontinue Date
-
Package Status
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 |