Duns Number:485050483
Device Description: 25mm syringe filter with 5.0 micron low protein binding Versapor® membrane
Catalog Number
6094184
Brand Name
Gardian 25 mm Syringe Filter
Version/Model Number
6094184
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"
-
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
-
Product Code
FPB
Product Code Name
Filter, infusion line
Public Device Record Key
2bbe40db-ad16-4077-bdbc-f1fc368ed1b9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |