Duns Number:002348191
Device Description: MAC(TM) Two-Lumen Central Venous Access Set with Integral Hemostasis Valve for use with 7 MAC(TM) Two-Lumen Central Venous Access Set with Integral Hemostasis Valve for use with 7 - 7.5 Fr. Catheters
Catalog Number
SI-11242
Brand Name
ARROW
Version/Model Number
IPN029775
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
K002507,K002507
Product Code
FOZ
Product Code Name
Catheter, intravascular, therapeutic, short-term less than 30 days
Public Device Record Key
7250081c-3754-4e90-86c6-d97fca24d93e
Public Version Date
February 04, 2020
Public Version Number
2
DI Record Publish Date
December 10, 2019
Package DI Number
40801902144483
Quantity per Package
5
Contains DI Package
30801902144486
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 |