Duns Number:002348191
Device Description: One-Lumen CVC Kit
Catalog Number
ASK-04301-TJ
Brand Name
ARROW
Version/Model Number
IPN036604
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
K820009,K820009,K820009
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
7915a559-c8be-41d7-91af-a928f2eccd4e
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
30801902114984
Quantity per Package
5
Contains DI Package
20801902114987
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 |