Duns Number:485050483
Device Description: 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hou 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use.
Catalog Number
AEF1E
Brand Name
Pall Supor® AEF Filter
Version/Model Number
AEF1E
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
K993379,K993379
Product Code
FPB
Product Code Name
Filter, infusion line
Public Device Record Key
a0c07149-f821-4f56-b617-43c6408d7994
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 20, 2016
Package DI Number
35034480104374
Quantity per Package
50
Contains DI Package
05034480104373
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |