Duns Number:002348191
Device Description: Central Venous Catheter with Blue FlexTip(R) for use only with Arrow MAC(TM) Two-Lumen Cen Central Venous Catheter with Blue FlexTip(R) for use only with Arrow MAC(TM) Two-Lumen Central Venous Access Device
Catalog Number
ML-00701
Brand Name
ARROW
Version/Model Number
IPN033212
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
-
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
e567d715-1fad-455c-a331-260aa746b397
Public Version Date
May 07, 2021
Public Version Number
3
DI Record Publish Date
July 08, 2020
Package DI Number
10801902100754
Quantity per Package
5
Contains DI Package
20801902100751
Package Discontinue Date
May 03, 2021
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 |