Duns Number:002348191
Device Description: Multi-Lumen CVC Kit
Catalog Number
CDC-15703-B1A
Brand Name
ARROW
Version/Model Number
IPN036599
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
K862056,K862056
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
eaac1a96-f817-4265-9bc2-d7235149c325
Public Version Date
March 08, 2022
Public Version Number
8
DI Record Publish Date
April 13, 2018
Package DI Number
20801902116783
Quantity per Package
5
Contains DI Package
30801902116780
Package Discontinue Date
March 05, 2022
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 |