Duns Number:002054419
Device Description: Pall Supor 1.2 micron Air Eliminating Filter for Intravenous use. 24 hour use.
Catalog Number
AEF2NT
Brand Name
Pall Supor® 1.2 Filter
Version/Model Number
AEF2NT
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
3933e24b-e3bf-421c-8d69-8484afa1de25
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 01, 2016
Package DI Number
30636207315435
Quantity per Package
40
Contains DI Package
00636207315434
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |