Duns Number:030899271
Device Description: Extension Set: 10" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are single-use Extension Set: 10" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration sets for use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All extension sets fluid paths are sterile, non-Pyrogenic are not made with natural rubber latex, and are not made with DEHP.
Catalog Number
FE01
Brand Name
Zyno
Version/Model Number
FE01
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
8285e118-70c2-4172-bacb-974297d7000b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20814371020369
Quantity per Package
6
Contains DI Package
10814371020362
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 |