Duns Number:002348191
Device Description: Central Venous Catheterization Kit
Catalog Number
AK-04212
Brand Name
ARROW
Version/Model Number
IPN033852
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
K781978,K781978
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
9505a1d3-4ad0-4a10-bef7-054563b6885f
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
December 01, 2017
Package DI Number
20801902004929
Quantity per Package
10
Contains DI Package
10801902004922
Package Discontinue Date
May 14, 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 |