Duns Number:002348191
Device Description: MAC(TM) Two-Lumen Central Venous Access Set with ARROWg+ard Blue(R) Access Device and Inte MAC(TM) Two-Lumen Central Venous Access Set with ARROWg+ard Blue(R) Access Device and Integral Hemostasis Valve for use with 7 - 7.5 Fr. Catheters
Catalog Number
SI-21142
Brand Name
ARROW
Version/Model Number
IPN030361
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
K011761,K011761
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
6d8d81aa-59b8-4c32-9e8e-a7ed41b9308e
Public Version Date
February 12, 2020
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
30801902024542
Quantity per Package
5
Contains DI Package
00801902024541
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 |