Duns Number:002348191
Device Description: Radial Artery Catheterization Kit with Sharps Safety Features
Catalog Number
ASK-04020-UNC
Brand Name
ARROW
Version/Model Number
IPN036980
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
K810675,K810675
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
7cbb436d-b623-41f8-9b79-6bf71cf20394
Public Version Date
February 18, 2019
Public Version Number
2
DI Record Publish Date
November 07, 2018
Package DI Number
30801902117848
Quantity per Package
10
Contains DI Package
20801902117841
Package Discontinue Date
February 11, 2019
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 |