Duns Number:030899271
Device Description: AX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve. AX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP.
Catalog Number
AX-80072
Brand Name
Zyno
Version/Model Number
AX-80072
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
K120685,K120685,K120685
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
87b3559c-f61a-4d4b-b087-34a4525e2773
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20814371020499
Quantity per Package
6
Contains DI Package
10814371020492
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |